Get your medical device
to market, faster.
The future of regulatory clearance begins here. One decision
and one empowered startup at a time.
The 510(k) bottleneck is real.
20–40 hours
of manual database searching just to find the right predicate device.
Days of cross-referencing
to identify the correct FDA product code and regulatory pathway.
$50K–$150K
in consulting fees and 3–6 months for a single submission.
Clearance AI is built to change that.
Three steps to regulatory clarity.
Describe Your Device
Use a guided wizard to describe your medical device and its intended use.
Find Your Pathway
AI identifies your FDA product code, device class, and best predicate devices.
Get Clear
Receive a regulatory pathway with auditable citations to real FDA data.
This is what Clearance AI delivers: product code identification, ranked predicate candidates with similarity scores, and auditable citations to FDA source documents.
Where we fit in your timeline.
Concept & R&D
Device design and technical specifications finalized.
Regulatory Strategy
Find predicates, product codes, and pathways in minutes.
Drafting & Submission
Compile clinical evidence and draft the 510(k) file.
FDA Review
Lower Refuse-to-Accept (RTA) risk through data-driven strategy.
Built for teams on the front lines.
Medical Device Startups
Preparing your first 510(k) without a dedicated regulatory team.
Regulatory Consultants
Managing multiple client submissions and need to move faster.
Device Manufacturers
Expanding your portfolio and scaling regulatory operations.
Built with rigor. Grounded in data.
Built by a biomedical engineer.
Doxa Thompson understands medical device regulation—not just AI.
Grounded in real FDA data.
Every claim cited to its exact source. No hallucinations. No invented regulation numbers.
Evaluation-tested.
Our AI has been tested on representative 510(k) cases with documented accuracy. Product code identification achieves 100% accuracy on our pilot test suite.
See evaluation results →
Building in public.
Follow the build from day one. Read the build log →
What early testers are saying.
I'm Doxa Thompson, a biomedical engineer turned AI engineer.
I've seen how painful the 510(k) submission process can be—the manual database searches, the cross-referencing of guidance documents, the expensive regulatory surprises. I built Clearance AI to handle the grinding research and drafting so regulatory professionals can focus on strategy and judgment. I'm building in public. The methodology, evaluation results, and build progress are shared transparently.
👤 Human-in-the-Loop
Clearance AI is a drafting tool for regulatory professionals. It does not submit to the FDA on your behalf. Human review is always required. You own the submission.
Join the Early Access List
Be first in. Early members get free access during the beta period.
Built by Doxa Thompson, biomedical engineer — I read every reply.