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Get a free 510(k) device classification review by email.

Submit your device facts and Cruxi's regulatory team will return a high-level classification direction, up to three alternates, key caveats, and a recommended next step—queued for real review, not auto-generated.

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Provide your device facts Contact info, intended use, technology, and disambiguation details are captured up front to give the reviewer everything needed.
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Cruxi reviews it in the background Your request enters a review queue instead of generating a fake instant answer. A real reviewer examines your submission.
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You receive a result link by email Once complete, your result page shows the classification direction, alternates, caveats, and next steps. Turnaround: 1–3 business days.

Free review deliverables

Four things you get back, every time.

The free review is designed to give you enough signal to make an informed decision about investing in a full 510(k) preparation—without wasting weeks on the wrong pathway.

category
Recommended classification direction

One primary classification pathway (Class I, II, or III) with the most likely FDA device class and product code family, based on your device facts.

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Up to three alternates

Alternative classification pathways with brief rationale for each—useful when your device sits between categories or has unusual features.

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Key caveats and disqualifying factors

Specific issues that could affect your chosen pathway—such as implantability, novel technology, or missing predicate—flagged before you invest further.

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Recommended next step

A concrete recommendation for what to do next: proceed with a full submission workflow, request a Pre-Sub meeting, consider De Novo, or engage a consultant.

Scope

What this review covers—and what it doesn't.

Understanding the scope helps you use the free review as the right tool for the right decision.

check_circleIncluded in free review
  • checkHigh-level device classification direction (Class I / II / III)
  • checkPrimary regulatory pathway recommendation (510k, De Novo, PMA)
  • checkUp to 3 alternate pathway options with rationale
  • checkKey caveats and known disqualifying factors
  • checkRecommended regulatory next step
  • checkResult link delivered by email
  • checkNo account creation required
  • checkZero cost
cancelNot included (available in paid workflow)
  • closeFull predicate device analysis with 510(k) numbers
  • closeSubstantial equivalence argument drafting
  • closeComplete regulatory assessment across eSTAR sections
  • closeEvidence plan and testing gap analysis
  • closeeSTAR section drafting and content generation
  • closeRTA (Refuse to Accept) prevention check
  • closeSubmission package assembly
  • closeExpert consultant review and sign-off

By the numbers

The FDA 510(k) program in context.

Understanding scale helps teams set realistic expectations before committing to a submission pathway.

~3,200
510(k)s cleared per year
FDA FY2022–2023 avg. — FDA.gov
~85%
Substantial equivalence rate for accepted 510(k)s
FDA CDRH Performance Reports — CDRH Transparency
90 days
Statutory review clock once RTA criteria are met
21 U.S.C. § 360(k); FDAMA 1997
>170,000
Total 510(k)s cleared since program launch in 1976
FDA 510(k) database — AccessData.FDA.gov

FDA device classification system

Class I, II, and III explained—with what they mean for your 510(k).

Under 21 CFR Part 860 and Section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA classifies all medical devices into one of three regulatory classes based on the risk they pose and the controls necessary to ensure safety and effectiveness. Knowing your class before starting a submission is not optional—it determines your pathway, your evidence burden, and your timeline.

Class I — General Controls
Lowest Risk
~47%

Class I devices are subject only to "general controls"—the baseline requirements of the FD&C Act (registration, listing, labeling, manufacturing quality systems, and prohibition against adulteration). The vast majority are exempt from 510(k) premarket notification under 21 CFR Parts 862–892.

Bandages Tongue depressors Manual stethoscopes Elastic bandages
Key regulation: 21 CFR § 860.3(c)(1) — "General controls alone are sufficient to provide reasonable assurance of safety and effectiveness."
Class II — Special Controls
Moderate Risk
~43%

Class II devices require both general controls and "special controls"—device-specific performance standards, post-market surveillance, patient registries, or other measures. Most Class II devices require a 510(k) premarket notification, though some are exempt. This is the primary target class for most 510(k) submissions.

Cardiac monitors Powered wheelchairs Infusion pumps Pregnancy test kits
Key regulation: 21 CFR § 860.3(c)(2) — "General controls alone are insufficient, and there is sufficient information to establish special controls."
Class III — PMA Required
Highest Risk
~10%

Class III devices support or sustain human life, are of substantial importance to preventing impairment, or present a potential unreasonable risk of illness or injury. They require Premarket Approval (PMA)—the most stringent pathway, requiring valid scientific evidence demonstrating reasonable assurance of safety and effectiveness.

Implantable pacemakers Cochlear implants Silicone gel-filled implants
Key regulation: 21 CFR § 860.3(c)(3) — "Insufficient information to determine that general controls and special controls would provide reasonable assurance of safety and effectiveness."
Important nuance: A Class III designation on a new device type does not automatically mean PMA. If no valid predicate exists, the sponsor may pursue De Novo classification (21 CFR Part 860, Subpart D), which—if granted—reclassifies the device to Class I or II and creates a new regulatory pathway with special controls. De Novo is not available for PMA-required devices where safety and effectiveness cannot be assured without clinical data. Source: FDA Guidance: De Novo Classification Process (Sept. 2021).

Regulatory pathway comparison

510(k) vs. De Novo vs. PMA vs. Exempt — side by side.

Choosing the wrong pathway before gathering evidence is one of the most expensive mistakes in medical device development. This table summarizes the four primary U.S. regulatory pathways based on FDA's publicly available guidance and performance data.

Factor 510(k) Notification De Novo Classification PMA (Premarket Approval) Class I Exempt
Target device class Primarily Class II (some I) Novel Class I or II Class III Class I (most)
Requires predicate? Yes No No No
Clinical data required? Sometimes Sometimes Almost always No
FDA statutory review clock 90 days (from RTA acceptance) 150 days (FDASIA 2012) 180 days N/A — no premarket review
eSTAR format required? Yes (most devices) Structured template PMA format No submission
Regulatory basis 21 U.S.C. § 360(k); 21 CFR Part 807 21 U.S.C. § 360c(f)(2); 21 CFR Part 860 Subpart D 21 U.S.C. § 360e; 21 CFR Part 814 21 CFR Parts 862–892 (device-specific)
Creates new predicate? Cleared 510(k) becomes predicate Yes — establishes new classification No — PMA approval only No
Typical industry cost $50K–$500K+ (prep) + FDA user fee ~$21K (FY2025) $50K–$300K+ (prep); FDA user fee waived $500K–$5M+ (prep) + FDA user fee ~$428K (FY2025) $0 (registration & listing fees apply)
Best for Devices with a legally marketed predicate of same intended use and technology characteristics Novel devices where general and special controls are sufficient but no predicate exists High-risk implantables; life-sustaining devices; devices with new intended uses that raise new safety questions Low-risk devices where general controls alone ensure safety

Sources: FDA Premarket Submissions overview; FDA MDUFA FY2025 user fees; De Novo guidance (Sept. 2021). Cost ranges are industry estimates only and vary substantially by device type, complexity, and consultant strategy.

How FDA determines classification

The seven factors FDA weighs under 21 CFR § 860.7.

Classification is not a lookup table. Under 21 CFR § 860.7, FDA applies a structured risk-benefit analysis when determining the appropriate classification for a device type. Understanding these seven factors will help you provide more useful information in the intake form below—and will help you understand your classification result when it arrives.

01
Intended use and indications for use

The single most important factor. FDA assesses what the device is designed to do, for whom, and in what clinical context. A device with the same technology but a different intended use can result in an entirely different classification. This is why the "intended use" field in our intake form is required and must be specific.

02
Patient population and vulnerability

Devices intended for pediatric, neonatal, or immunocompromised populations, or for use in emergency settings, attract heightened regulatory scrutiny. A blood pressure cuff intended for adult home use and one intended for critical care neonates are evaluated very differently under this factor.

03
Type and duration of body contact

Under 21 CFR § 860.7(d), the nature of contact—surface, mucosa, blood-contacting, implantable—and its duration (transient <24h, short-term ≤30d, long-term >30d) directly affect classification risk. Implantable long-term blood-contacting devices receive the highest scrutiny.

04
Degree of invasiveness

Non-invasive, external, invasive, and implantable represent increasing levels of regulatory concern. The invasiveness determination feeds directly into the biocompatibility evaluation framework (ISO 10993 series) and the required testing evidence matrix.

05
Novelty of technology or intended use

Technological novelty—new algorithms, new materials, novel mechanisms of action, or AI/ML-driven outputs—is a key escalation factor. FDA's Predetermined Change Control Plans guidance (2024) and the AI/ML Action Plan address how continuously learning software affects classification stability.

06
Consequences of device failure

FDA's hazard analysis framework asks: what happens if this device fails or malfunctions? A diagnostic device that generates false negatives affecting treatment decisions is assessed differently from one used for informational purposes only. This factor is where intended use precision matters most—e.g., "aid in diagnosis" vs. "diagnose" triggers materially different regulatory treatment.

07
Marketed device history and predicate availability

FDA considers whether cleared predicate devices exist with the same or similar intended use and technological characteristics. The availability of an appropriate predicate is not just a 510(k) eligibility question—it informs classification by demonstrating that the risk profile has been previously assessed and found to be manageable with existing controls.

★
Bonus: Software and AI/ML considerations

FDA's Policy for Device Software Functions (Sept. 2022) and the clinical decision support framework distinguish between software that is a medical device (SaMD) and software that is not. Classification of AI/ML-enabled SaMD further depends on the significance of the information provided and the state of the healthcare situation or condition.

Regulatory basis: The classification framework described above is derived from 21 CFR Part 860 (Medical Device Classification Procedures), Section 513 of the FD&C Act (21 U.S.C. § 360c), and FDA CDRH's internal classification policies as described in the Guidance for Industry: 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (July 2014). The seven-factor framework is a summary of how FDA applies its statutory risk-benefit standard, not a verbatim regulatory enumeration.

Primary source library

The FDA guidance documents every 510(k) team needs to read.

These are the authoritative, current FDA guidance documents that directly govern 510(k) classification and submission. Each link goes to the official FDA.gov source. Reading these before starting your submission is not optional—they define FDA's current expectations.

description
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
FDA Guidance Final — July 28, 2014 The foundational document for understanding substantial equivalence. Defines same intended use, same/different technological characteristics, and what constitutes a valid 510(k) predicate. Mandatory reading before any 510(k) strategy is developed.
description
Refuse to Accept Policy for 510(k)s
FDA Guidance Revised — September 13, 2019 Defines the administrative and substantive criteria FDA uses to decide whether to accept a 510(k) for review. Understanding RTA criteria is the first step to preventing costly rejections. Approximately 10–15% of 510(k)s receive RTA letters annually.
description
De Novo Classification Process (Evaluation of Automatic Class III Designation)
FDA Guidance Final — September 2021 Defines when and how a device without a predicate can request De Novo classification rather than PMA. Critical reading for novel Class II-risk devices where no predicate exists. De Novo clearances create new predicates for subsequent 510(k) submissions.
description
Policy for Device Software Functions and Mobile Medical Applications
FDA Guidance Revised — September 27, 2022 Defines which software functions are regulated as medical devices and which are not. The three-tier framework (functions FDA intends to enforce / not enforce / exempt) determines whether your SaMD requires a 510(k). Essential for any AI, digital health, or software-driven device team.
description
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
FDA Guidance Draft — April 2023 Defines how AI/ML-enabled devices that continuously learn after clearance can be managed through a Predetermined Change Control Plan (PCCP) rather than requiring a new 510(k) for every algorithm update. Critical for any continuously learning SaMD.
storage
FDA Product Classification Database (CDRH)
FDA Database Continuously Updated The authoritative source for FDA device classifications, product codes, and device types. Search by device name, product code, or 21 CFR part. Every classification review—free or paid—ultimately traces to an entry or gap in this database.
storage
FDA 510(k) Premarket Notification Database
FDA Database Continuously Updated — 170,000+ records Searchable database of every cleared 510(k) since 1976. Essential for predicate research: search by device name, product code, or applicant to find cleared predicates, understand what performance data was accepted, and model your substantial equivalence argument.
description
eSTAR: Electronic Submission Template and Resource — Help Documentation
FDA Resource Current eSTAR version FDA's structured electronic format for 510(k) submissions, now required for most device types. The eSTAR template contains 18 sections aligned with FDA's review framework. Understanding the eSTAR structure before starting your submission prevents major rework downstream.

Common mistakes

Six classification pitfalls that delay clearance—and how to avoid them.

Most 510(k) delays and RTA letters are preventable. Based on FDA's publicly available RTA data and common patterns in submitted devices, these are the errors that most frequently send teams back to square one.

01
Overly broad or clinically imprecise intended use statement

Intended use statements like "monitors patient health" or "assists clinicians" are the single most common cause of substantial equivalence failures. FDA requires that the intended use be specific enough to be matched against a predicate. Vague language forces reviewers to request clarification—adding months to the review. Per FDA's 2014 substantial equivalence guidance, the intended use comparison must address the specific indication for use, not a category.

lightbulb Fix: Write your intended use as: "[Device] is intended to [specific function] for [specific patient population] in [specific clinical setting]." Mirror the language of a cleared predicate's 510(k) summary.
02
Selecting a predicate based on similarity of name, not intended use

Teams frequently identify a predicate because the device names sound similar, without verifying that the predicate's cleared intended use, patient population, and use setting actually match. A 510(k) argument built on a name-match predicate will fail the substantial equivalence test. Under 21 CFR § 807.87, the predicate must have the same intended use—not just a similar product description.

lightbulb Fix: Search the FDA 510(k) database by product code (not device name) and verify the predicate's Summary of Safety and Effectiveness for intended use alignment before building your argument.
03
Misclassifying SaMD under the wrong software policy tier

Many software teams assume their app is not a medical device because it "only displays information." FDA's 2022 Software Policy guidance makes clear that software that analyzes patient-specific data, supports clinical decision-making, or triggers a clinical action is likely regulated as a SaMD—regardless of whether it runs on a phone, cloud server, or embedded hardware.

lightbulb Fix: Apply the significance-of-information and state-of-healthcare-situation framework from FDA's guidance before assuming software exemption. When in doubt, submit a Q-Sub (Pre-Sub) meeting request to get FDA's informal opinion.
04
Assuming Class I exemption without verifying the specific regulation

"Class I devices don't need a 510(k)" is true—but only for the specific device types listed as exempt in 21 CFR Parts 862–892. A device that seems low-risk may still require a 510(k) if it falls outside the enumerated exempt categories or if the exemption is conditioned on specific limitations of intended use. Dozens of teams have gone to market without a 510(k) for devices that were later found to require one.

lightbulb Fix: Look up the specific product code in FDA's Product Classification Database. Check whether the 510(k) exempt column is "Yes" and whether any conditions or limitations apply to your device's intended use.
05
Pursuing a 510(k) for a device that should be De Novo

When no suitable predicate exists, some teams cycle through multiple 510(k) submissions before accepting that their device is truly novel. FDA's response to a non-substantial-equivalence (NSE) determination is not a rejection of the device—it is a signal that the device may be appropriate for De Novo. The FDA De Novo guidance (Sept. 2021) clarifies that De Novo is available without a prior NSE determination.

lightbulb Fix: If your preliminary predicate search yields no matches in the same product code family, consider De Novo from the outset rather than filing a 510(k) you know will receive an NSE. A Q-Sub meeting can validate this strategy before you invest in full submission preparation.
06
Incomplete or missing performance testing for technological differences

When a 510(k) argues that technological differences do not raise new safety or effectiveness questions, it must support that argument with performance data. RTA reviews cite missing performance data as one of the top five causes of administrative non-acceptance. Per FDA's 2014 guidance, if your device differs from its predicate in a technological characteristic that could affect safety or effectiveness, you must provide data showing that it does not—not just assert it.

lightbulb Fix: Build your evidence plan before your testing plan. Map every technological difference to a safety/effectiveness question, identify the relevant performance standard (FDA-recognized or otherwise), and ensure test results are available before you write Section 12 of your eSTAR.

Submit your device

Fill out the intake form below.

The more detail you provide, the more accurate and useful your classification result will be. Required fields are marked. The form takes roughly 10 minutes to complete thoroughly.

contact_mailContact

We use this to deliver your result link and follow up when the review is complete. We will never use your details for unsolicited marketing.

medical_servicesDevice Intake

These are the core facts the reviewer needs to form a useful high-level classification direction. Be as specific as possible—vague descriptions yield less useful results.

State the device purpose clearly: e.g. "intended to monitor heart rate and detect irregular cardiac rhythms in adult patients in a clinical outpatient setting."
Include whether the device is software-only, hardware-only, or combined; whether it uses AI/ML; whether it is connected to a network or cloud.
Example: "Similar to the Acme CardioTrack (K210123) and Medco RhythmScan (K190456). Our device adds cloud connectivity."

manage_searchDisambiguation

These answers help the reviewer reduce false classification matches. They are especially important for novel, software-driven, or multi-function devices. Skip only if truly not applicable.

After submission, you will be redirected to your status page and will also receive a link by email when the review is complete. No account is created.
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After your result

Three clear paths forward.

Your result page will explain which path fits your situation. Here's what each path means.

rocket_launch
If the result looks promising

Move into the paid Cruxi workflow to continue with predicate analysis, full regulatory assessment across all 18 eSTAR sections, evidence planning, and drafting. Get submission-ready in a fraction of the traditional time.

psychology
If the device is still ambiguous

Use the result as a triage input, then confirm the direction with your internal RA/QA lead or a regulatory consultant before committing to a full submission. The free review will surface the specific ambiguity to resolve.

groups
If you need expert support now

Go directly to the Cruxi consultant directory or start the paid workflow with a consultant attached from day one. Vetted FDA 510(k) consultants are available for strategy, authoring, predicate research, and Pre-Sub support.

Questions & answers

Frequently asked questions.

Everything you need to know before submitting your device for a free 510(k) classification review.

What does the free 510(k) classification review include?expand_more
The free review includes one high-level recommended FDA classification direction, up to three alternate classification pathways with brief rationale, key caveats that could affect your pathway choice, and a recommended regulatory next step. It does not include a full predicate analysis, evidence plan, complete regulatory assessment, or eSTAR drafting—those are available in the paid Cruxi workflow.
How long does it take to receive my result?expand_more
Results are queued for real expert review rather than auto-generated. Typical turnaround is 1–3 business days. You will receive an email with a link to your result page when the review is complete. The queue-based model ensures you receive a genuine, considered classification opinion rather than an unverified instant output.
Do I need to create an account?expand_more
No. The free review requires only a name, work email, and device details. There is no account creation, credit card, or commitment required. Your result link is delivered by email when the review is complete.
What information do I need to provide about my device?expand_more
Required fields are: device name, intended use, device description, and technology summary. Optional but highly recommended: common name, device type, indications for use, target users, use setting, anatomical site, energy source, patient contact, contact duration, sterility, implantability, software, IVD status, connectivity, and known comparators. The disambiguation section (what the device does and does not do) significantly improves result accuracy.
What's the difference between this free review and the paid Cruxi workflow?expand_more
The free review is a triage tool—it tells you whether your device likely fits a 510(k) pathway. The paid workflow takes you all the way from classification through submission-ready package: complete predicate analysis with actual 510(k) numbers, full regulatory assessment across all 18 eSTAR sections, an evidence plan, AI-drafted eSTAR content, RTA prevention checks, and optional expert consultant review. The paid workflow reduces preparation time by 50–70% compared to traditional methods.
Can this review tell me my FDA device class (I, II, or III)?expand_more
Yes. The review will indicate the likely device class and the probable regulatory pathway based on your device facts. Final classification must be confirmed against FDA's official product code database (accessible via FDA.gov) and, if needed, a 513(g) Request for Information. The free review is a starting direction—not a definitive regulatory determination—and should be confirmed by a qualified regulatory professional.
What are common reasons a device does not qualify for a 510(k)?expand_more
Common reasons include: (1) no suitable predicate with the same intended use and technological characteristics; (2) the device raises novel safety or effectiveness questions requiring clinical data beyond what 510(k) supports; (3) the device is Class III, requiring PMA; (4) the intended use is novel enough to warrant De Novo classification; or (5) a regulation explicitly requires PMA for that device type. The free review flags the most likely disqualifying factors based on your submission.
What is a 510(k) submission and why is it required?expand_more
A 510(k) is a premarket notification submitted to the FDA demonstrating that your medical device is substantially equivalent to a legally marketed predicate device. Most Class II and some Class I devices require 510(k) clearance before they can be commercially distributed in the United States. The submission covers device description, intended use, technological characteristics, performance testing, labeling, and a substantial equivalence comparison. FDA's standard review clock is 90 calendar days from the date the submission is accepted (not rejected under RTA).
Is this review a substitute for a regulatory consultant?expand_more
No. The free classification review is an informational starting point. It does not replace qualified regulatory advice from a licensed professional. Final classification, product code selection, predicate strategy, and submission decisions must be confirmed by a qualified regulatory affairs professional who has full knowledge of your device, its clinical context, and applicable FDA guidance documents. Cruxi's paid workflow and consultant directory can connect you with vetted FDA 510(k) experts.
What happens to my device information after submission?expand_more
Your submission is stored securely and used only to perform the requested review. Cruxi does not sell or share your device information with third parties. Your result is accessible via a unique link sent to your email. If you have questions about data handling, contact support@cruxi.ai.

References & primary sources

  1. 1 U.S. Food & Drug Administration. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. Guidance for Industry and FDA Staff. July 28, 2014. fda.gov/media/80100/download
  2. 2 U.S. Food & Drug Administration. Refuse to Accept Policy for 510(k)s. Guidance for Industry and FDA Staff. September 13, 2019. fda.gov/media/92362/download
  3. 3 U.S. Food & Drug Administration. De Novo Classification Process (Evaluation of Automatic Class III Designation). Guidance for Industry and FDA Staff. September 2021. fda.gov/media/101920/download
  4. 4 U.S. Food & Drug Administration. Policy for Device Software Functions and Mobile Medical Applications. Guidance for Industry and FDA Staff. September 27, 2022. FDA.gov guidance page
  5. 5 U.S. Food & Drug Administration. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. Draft Guidance. April 2023. fda.gov/media/122535/download
  6. 6 Electronic Code of Federal Regulations. 21 CFR Part 860 — Medical Device Classification Procedures. ecfr.gov — 21 CFR Part 860
  7. 7 Electronic Code of Federal Regulations. 21 CFR Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (Subpart E: Premarket Notification Procedures). ecfr.gov — 21 CFR Part 807
  8. 8 U.S. Food & Drug Administration. 510(k) Clearances by Fiscal Year. CDRH. fda.gov — 510(k) Clearances
  9. 9 U.S. Food & Drug Administration. CDRH Transparency: Performance Reports and Goals. fda.gov/about-fda/cdrh-reports/cdrh-transparency
  10. 10 U.S. Food & Drug Administration. FDA Product Classification Database. accessdata.fda.gov — Product Classification
  11. 11 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360c (Section 513). Classification of Devices. uscode.house.gov
  12. 12 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360(k) (Section 510(k)). Premarket Notification. uscode.house.gov