510(k) Regulatory Pathway Assessment & Roadmap
Get a clear 510(k) regulatory strategy for your medical device in 1 business day.
Cruxi analyzes your device to define the FDA pathway, likely product code, candidate predicates, and a testing roadmap you can share with your team or consultant.
Delivered as a written 510(k) regulatory roadmap PDF and secure web report.
AI-powered, human-reviewed. 1 business day turnaround.
What's Included in Your 510(k) Regulatory Pathway Assessment
Regulatory Pathway Recommendation
Clear assessment of whether your device is likely headed toward a 510(k), De Novo, PMA, or may fall under an exemption or enforcement discretion (with caveats and assumptions).
Device Classification & Product Code Options
1–3 likely FDA product codes and regulations, mapped to your intended use, indications for use, risk profile, and core technology.
Predicate & Competitor Landscape
Short list of relevant 510(k) predicate candidates and comparator devices, with notes on indication and technology similarity and potential fit as your predicate device.
Testing & Standards Roadmap
High-level 510(k) testing requirements for your device class: typical bench tests, biocompatibility, electrical safety/EMC, software/cybersecurity, usability, and clinical needs where applicable, plus key standards to consider.
Actionable Next Steps
A concise, 2–3 page written 510(k) regulatory strategy and roadmap summarizing recommended next steps, open questions, and how this assessment can feed into a full 510(k) submission.
Cost Estimation Complexity and Business Burden
High-level cost and timeline estimates for your regulatory pathway, including FDA fees, typical testing costs, consultant fees (if applicable), and expected timeline to clearance. Assessment of business burden and resource requirements to help with planning and budgeting.
Who This 510(k) Regulatory Strategy Is For
This 510(k) regulatory pathway assessment is designed for:
- Early-stage medtech teams planning a new device and trying to understand 510(k) requirements.
- Startups with a prototype who need clarity on FDA device classification and regulatory pathway before investing in testing.
- RA/QA leaders who want a structured 510(k) regulatory roadmap they can share internally.
- Regulatory consultants who want a fast, AI-assisted assessment to scope a new client project.
Important: This is a planning-stage product designed to clarify your 510(k) regulatory pathway and requirements. It is not a replacement for a full 510(k) submission, but rather the first step before one.
How the 1-Day 510(k) Pathway Assessment Works
Share Your Device Details
Complete a short intake form with your device name, intended use, target population, technology, form factor, and any known competitor products.
AI-Driven Regulatory Analysis
Cruxi's regulatory engine runs device classification, 510(k) predicate analysis, and regulatory assessment across thousands of FDA product codes, regulations, guidance documents, and cleared 510(k) summaries. It uses the same specialized agents that power our full 510(k) workflow, tuned specifically for medical device language.
Human Review & Refinement
An expert reviews the AI-generated 510(k) regulatory strategy, validates the pathway recommendation and product code options, and refines the narrative roadmap.
Receive Your Regulatory Roadmap in 1 Business Day
You receive a secure link and downloadable PDF with your full 510(k) regulatory pathway assessment, product code options, predicate landscape summary, and testing roadmap.
Powered by the Cruxi Regulatory Engine
Under the hood, your 510(k) regulatory pathway assessment is generated by a set of specialized AI agents working on top of Cruxi's curated FDA medical device knowledge base.
- Classification agent – analyzes your intended use, indications, risk and technology to propose likely FDA device classification and product code options.
- Predicate agent – searches cleared 510(k) summaries to identify relevant predicate and comparator devices and highlight key similarities and differences.
- Testing & risk agent – maps your device and product code to typical 510(k) testing requirements and recognized standards for your category.
These agents are fed from a regularly updated corpus of FDA device regulations, product codes, 510(k) summaries, guidance documents, and recognized standards. A human reviewer then validates and refines the final roadmap before it is delivered.
Why Use Cruxi for Your 510(k) Regulatory Pathway Assessment?
Built for FDA 510(k) Devices
Cruxi focuses on FDA medical device regulation and 510(k) strategy, combining device regulations, product codes, guidance documents, cleared 510(k) summaries, and other public FDA data into one continuously updated platform.
AI-Powered, Expert-Reviewed
The assessment leverages Cruxi's AI classification and predicate search engine, then adds human review to keep the 510(k) regulatory strategy grounded and practical.
Faster Than Traditional Consulting
Instead of weeks of back-and-forth, you receive a concrete 510(k) regulatory roadmap in 1 business day, with clear next steps and testing considerations.
Designed to Feed the Full 510(k) Process
Your pathway assessment can feed directly into Cruxi's 510(k) submission services, microservices, or an external regulatory consultant of your choice.
Learn more about Cruxi 510(k) submission services | See regulatory analytics for 510(k) product codes
What Cruxi Does vs. Human Consultants
Cruxi's AI-powered assessment combines exhaustive analysis with human expertise to deliver insights that would be impractical or impossible for humans alone to achieve at scale.
Mass-Scanning Regulations & Guidance
Cruxi: Scans 2,300+ regulations and thousands of guidance documents in seconds to identify what applies to your device.
Human limitation: Manually searching, reading, and interpreting each source is practically impossible under time and budget constraints.
Advanced Predicate Matching
Cruxi: Matches your device against thousands of product codes and tens of thousands of cleared devices using complex algorithms analyzing indications, technology, and risk profiles.
Human limitation: Humans typically scan a handful of devices and rely on experience; nobody can manually compare against tens of thousands consistently.
Safety & Recall Intelligence
Cruxi: Evaluates MAUDE events, recalls, and safety communications together when ranking predicates and shaping your regulatory strategy.
Human limitation: Humans rarely have time to deeply cross-check adverse events and recalls for every candidate predicate in real time.
Device-Specific Testing Matrix
Cruxi: Generates a device-specific testing matrix in seconds (bench, software, EMC, biocompatibility, electrical safety, usability, cybersecurity) mapped to regulations, guidance, and standards.
Human limitation: Manually stitching this together from regulations, guidance, and dozens of standards is slow, error-prone, and often inconsistent.
The Best of Both Worlds
Cruxi does what no human team can realistically do at scale or speed: mass-scanning regulations, codes, predicates, recalls, MAUDE events, and guidance in seconds without getting tired.
But Cruxi is not a replacement for experts. Cruxi + experienced human regulatory professionals = the highest quality 510(k) regulatory pathway assessment. You bring judgment, ethics, and real-world context. Cruxi brings exhaustive coverage, speed, and consistency. Together, you get clearer pathways, stronger strategies, and fewer expensive surprises.
510(k) Regulatory Pathway Assessment – Frequently Asked Questions
Is this the same as a full 510(k) submission?
No. This is a focused 510(k) regulatory strategy and pathway assessment. It gives you a clear 510(k) roadmap, but it does not create a complete submission package by itself.
What information do you need from us?
We typically need your device name, intended use and indications for use, target population, form factor, core technology, and any known predicate or competitor devices. You don't need a complete design history file to benefit from this assessment.
Do you guarantee that FDA will agree with the pathway or product code?
No one can guarantee a specific FDA decision. This assessment provides a reasoned 510(k) regulatory strategy and pathway recommendation based on current regulations, guidance, and precedent, but final decisions always rest with FDA.
What if our device turns out to be better suited for De Novo or PMA?
If the analysis shows that a 510(k) pathway is unlikely or risky, the assessment will explain why and outline alternate pathways (such as De Novo or PMA) and the implications for testing and timelines.
Can this assessment be used by our existing regulatory consultant or law firm?
Yes. The written 510(k) regulatory roadmap is designed to be shared with internal teams, external consultants, or legal counsel as a starting point for deeper work.
Do you offer full 510(k) preparation and submission services?
Yes. Cruxi can help generate draft 510(k) content across eSTAR sections and connect you with an expert for in-depth review. You can learn more about our 510(k) services here.
How much does the assessment cost?
Pricing is displayed at checkout and may vary depending on your configuration. The goal is to keep this a low-friction first step before a full 510(k) project.
Ready to Clarify Your 510(k) Regulatory Pathway?
Get a 510(k) regulatory pathway assessment and roadmap for your device in 1 business day, and move forward with confidence.
Get My 510(k) Regulatory Pathway Assessment