Regulatory Intelligence

510(k) Predicate
Finder

Discover predicate devices, analyze risk signals, and build substantial equivalence arguments for FDA submissions.

200K+510(k) clearances
5 minavg. analysis
FDAofficial data
How it works
1

Describe Your Device

Enter a natural language description of your medical device, a product code, or use guided fields for precision.

2

AI Finds Predicates

We search the FDA 510(k) database, score candidates by similarity, and pull risk signals from MAUDE and recall databases.

3

Build Your Case

Review scored candidates, compare side-by-side, generate substantial equivalence arguments, and export reports.

Medical professional analyzing diagnostic imaging on tablet

Every 510(k) submission begins with finding the right predicate. We make that search faster and smarter.

Data Sources
510(k) Database
Cleared device records
MAUDE
Adverse event reports
Recalls
Enforcement actions
FDA Standards
Recognized standards