Welcome Predicate Search

510(k)

Search through 510k submissions to find predicates for your device.

Using our AI search tools you can search through over 40,000 510(k) Summary documents or 510(k) submissions using natural language searches.

PMA

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.More info

Classifications

Product classification database More info

De Novo

The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.More info

Adverse Events

The FDA Adverse Event Reporting System (FAERS) database.More info

Recalls

Medical Device RecallsMore info