510(k) Predicate Device Finder
Identifying the right predicate device is the most critical first step in your 510(k) submission. Our SittuAI-powered search analyzes the FDA 510(k) database to find the strongest predicate matches for your device — turning weeks of manual research into minutes.
How It Works
Follow this three-step process to find your strongest predicate devices
Search Predicate Library
Search our indexed database of thousands of cleared 510(k) devices. Get instant relevance-ranked results to identify potential predicate matches.
Expand & Deep Scan
No strong match found? Run a comprehensive scan that discovers, downloads, and indexes new devices from the FDA database for your submission.
Deep Scan — Discover New Predicate Devices
Our AI will search the FDA database, analyze relevance, and index matching devices for you
Tips for Best Results
- Always search the library first — your predicate may already be indexed from a previous scan
- Be specific in your intended use — include patient population, clinical setting, and device function for better matches
- Aim for 65%+ relevance — matches above this threshold are strong predicate candidates worth reviewing
- Run the deep scan once per category — newly discovered devices are permanently added to the library for all future searches
- Validate with original submissions — use search results as a starting point, then review the full FDA 510(k) summaries