medical_servicesFree 510(k) Device Assessment

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Get instant regulatory insights for your medical device. Enter your device information below and receive a quick assessment including classification, regulatory pathway, timeline estimates, and key requirements.

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info This free tool gives you a fast, high-level snapshot. Detailed paid services use Cruxi's FDA-connected and trained AI engine for full pathway analysis and 510(k) planning.

Device Name *

Device Type *

Intended Use / Indications for Use *

Do you know your device class? (Optional)

Analyzing your device...

assessmentYour 510(k) Regulatory Assessment

Based on the information provided, here's your quick regulatory assessment.

This is a high-level, automated snapshot based on typical patterns for your selected device type. It is not formal regulatory advice.
Our paid assessments and full workflow connect to Cruxi's FDA regulatory knowledge base and deployed AI agents (regulations, product codes, 510(k) summaries, recalls, etc.) for much deeper analysis.

Device Classification

Class II

Most likely classification based on device type

Regulatory Pathway

510(k)

Traditional premarket notification

Estimated Timeline

90-120 days

FDA review time after submission

FDA User Fee

~$21,000

Standard 510(k) submission fee (2025)

keyKey Requirements & Considerations

What should you do next?

You've just seen a quick regulatory snapshot for your device. Here's how you can go deeper with Cruxi depending on where you are:

Option 1 – Detailed Regulatory Pathway Assessment

Best if you're still asking: "Is this definitely 510(k)? Could it be De Novo or PMA?"

What you get:

510(k) vs De Novo vs PMA analysis tailored to your device
Deeper reasoning on classification & product codes
Identification of key risk factors and data gaps
A written summary you can share internally or with a consultant

assessment Run Regulatory Pathway Assessment $300 (one-time)

Option 2 – Full 510(k) Workflow with Cruxi

Best if you're confident you're on a 510(k) path and want to get the submission done.

What you get:

Everything in the Regulatory Pathway Assessment
Predicate device analysis and shortlisting
Testing & evidence roadmap (bench, software, EMC, biocomp, etc.)
Drafting support for key 510(k)/eSTAR sections
A structured workspace to manage requirements, docs, and tasks

play_arrow Start 510(k) Submission Workflow $1,000 (per device) Requires Google sign-in to create your secure workspace. No spam, ever.

Consultant review is optional and priced separately. Cruxi is designed to reduce how many consultant hours you need.

Why use Cruxi and a consultant – not just a consultant?

Cruxi sits in the middle between you and traditional regulatory consulting. Instead of paying a consultant to do all the heavy lifting, we let each side do what they do best.

compare_arrowsSignificant Quality Boost – Two opinions instead of one

Cruxi provides a data-driven analysis: pathway, classification, product codes, predicates, and testing expectations based on FDA databases. Your consultant brings invaluable experience, nuanced judgment, and real-world FDA knowledge. Together, you gain two independent perspectives, validating each other's work and catching potential issues, ensuring a higher quality submission. You effectively get a double check on your regulatory reasoning, which can dramatically improve the quality and robustness of your submission.

auto_awesomeSignificant Cost Reduction – Consultants finish up, not start from scratch

Traditionally, consultants spend 40–60 hours on foundational groundwork: digging through product codes, searching old 510(k)s, building testing matrices, and drafting boilerplate sections. With Cruxi, this heavy lifting is largely automated and completed before a consultant even begins. Their role shifts to high-value finishing and polishing: challenging assumptions, refining arguments, adjusting indications/claims, and preparing for FDA questions. This can help reduce their hours (and fees) significantly—often cutting costs by up to 50–80% and saving thousands of dollars per submission.

person_searchYou get matched to the right consultant

Because Cruxi has already analyzed your device and candidate product codes, we can match you with consultants who actually live in your regulation + product code space, avoiding the "generic RA" mismatch that leads to slow, expensive back-and-forth.

control_cameraYou stay in control of your submission

All the structure, reasoning, and drafts live in your Cruxi workspace. If you ever change consultant, you don't start from zero. Your team can see the logic, not just a finished PDF.

Short version: Cruxi does the heavy analysis; your consultant does the high-value judgement.

Fewer hours, better fit, and two opinions instead of one. In many cases this can cut consultant hours — and fees — by 50–80%, often saving thousands of dollars per submission.