510(k) Copilot finds your predicate devices in the live FDA clearance database, builds your substantial-equivalence comparison, and drafts your core submission sections — every draft reviewed by a physician-scientist before it reaches you.
Free for the first 20 device companies · no subscription required · 48-hour turnaround
You bring the device. We bring the regulatory evidence, structured the way an FDA reviewer expects to see it.
A short intake: what the device does, its intended use, and the technology behind it. Takes 15 minutes — no regulatory vocabulary required.
We identify your FDA product code and classification, then search every relevant clearance in the FDA database to find and rank predicate candidates — real devices, real K-numbers, with clearance dates and applicants.
A substantial-equivalence comparison table and first drafts of your device description, indications for use, and SE discussion — mapped to FDA eSTAR headings and reviewed by a physician-scientist before delivery.
No "contact sales." No hourly billing. You know the price before you start — and every deliverable includes human expert review.
Physician-scientist with 55+ peer-reviewed publications in translational medicine, and founder of Epigenuity, where he builds clinical decision-support and diagnostic software. 510(k) Copilot grew out of navigating the FDA regulatory pathway for clinical software firsthand.
Most 510(k) tools are built by software companies guessing at what regulators want. Most consultants bill by the hour for work that is 60% document assembly. 510(k) Copilot sits deliberately in between: software does the exhaustive part — searching thousands of FDA clearance records, structuring comparisons, assembling drafts — and a physician-scientist does the judgment part, reviewing every deliverable before it reaches you.
That's why we can put prices on this page instead of asking you to book a discovery call with a sales team, and why a 10-person device startup gets the same quality of predicate analysis a strategic consultant would deliver — in days, at a tenth of the cost.
We are deliberate about what we are not: we are not your regulatory counsel, and we never claim AI replaces regulatory judgment. We produce evidence-grounded drafts your team — or your consultant — finishes and owns.
No. We produce research and drafts, not regulatory decisions. Every predicate candidate is a real cleared device pulled from the FDA's own 510(k) database with its actual K-number — nothing is invented by a language model. Drafts are starting documents for your team or consultant to finish; a human expert reviews every deliverable before you receive it.
That's one of the most valuable things to learn early. If our search shows no viable predicate, we'll tell you plainly — and outline what that means for your pathway (De Novo, 513(g), or a pre-submission conversation with FDA) before you spend consultant money.
Yes. Your intake is covered by a mutual NDA on request, and we never use one client's device information in work for another. The FDA data we search is public; your data is not.
Absolutely — several of our early users are consultants who use the Copilot to cut document-assembly time on their own engagements. If you already have counsel you trust, our deliverables slot into their workflow.
Any device on the 510(k) pathway. Our deepest expertise is software-as-a-medical-device and AI/ML-enabled devices — the fastest-growing category of FDA clearances.
Tell us about your device in two sentences. Within 48 hours you'll have ranked predicate candidates and an SE gap table — free for the first 20 companies, no strings.
Prefer email? Write to admin@epigenuity.com · Prefer a call? Include your number and we'll reach out.