175,000+ FDA 510(k) clearances · indexed daily

Find your 510(k) predicate. Build the submission. Move on.

Built for the people behind every 510(k) — consultants, founders, and in-house RA teams.

Search 142k+ 510(k) clearances by name, K-number, product code, or intended use
Compare predicates side by side with differences tinted automatically
Organize shortlists per submission across client engagements
Export submission-ready PDFs that drop into Section 4 of an eSTAR

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Built for the people who do this for a living

Independent regulatory consultants Device startup founders RA/QA at small manufacturers Submission-prep CROs

A 510(k) workspace, not another database

Built around the three things you actually do all day.

01 / How it works

Search, compare, export — in 20 minutes.

Three steps from first search to submission-ready PDF — designed for the way regulatory consultants actually work.

See the workflow → 02 / Features

Everything that should be in one tool, finally is.

Full-text search, side-by-side comparison with diff highlighting, project shortlists, branded PDF export.

Browse features → 03 / Pricing

One billable hour pays for the month.

Starter $199, Pro $399, Enterprise on request. 14-day free trial on all plans.

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