FDA 510(k) Substantial Equivalence Predicate Code Screener
Screens medical device 510(k) premarket notifications against predicate device product codes and regulation numbers.
Notice: engineering verification utility. Use test or de-identified data and verify results independently before relying on them.
How it works
Standard: FDA 510(k) Substantial Equivalence Decision Making Process 21 CFR Part 807
Formula: Verify 3-letter product code syntax and FDA regulation number (e.g. 21 CFR 870.1250)
Checks: Valid 3-letter product code format
Calculated locally in browser memory; nothing leaves your browser.
Deterministic local-first client-side execution. Provided as-is without warranty.