510(k) Database Pro
Search the Complete FDA
510(k) Database.
Find predicate devices, track competitor clearances, and monitor real-time 510(k) decisions — all in one searchable interface built for regulatory professionals.
Access for $97/monthCancel anytime. No long-term contracts.
Built for regulatory professionals
🔍
Predicate Device Research
Search the full FDA 510(k) database by product code, applicant, device name, or decision date. Find the right predicate in minutes, not hours.
📈
Competitor Intelligence
Track competitor submissions and clearances in real time. Know when a new device enters your market before your competitors tell you.
⚡
Real-Time Clearance Tracking
Get notified of new 510(k) clearances as they happen. Filter by product code, review panel, or third-party review status.
More than a search engine
✓
Complete FDA 510(k) database
Every 510(k) submission and decision, searchable and filterable
✓
Advanced filtering
Filter by product code, applicant, decision type, date range, and review panel
✓
Predicate chain mapping
Visualize predicate relationships to build your submission strategy
✓
Substantial equivalence analysis
Compare device characteristics across clearances for SE arguments
✓
Export and reporting
Download search results and generate reports for your regulatory submissions
✓
Daily database updates
New clearances and decisions added as soon as FDA publishes them