Programmatic Regulatory Reference
FDA 510(k) Clearance & Predicate Device Directory
A structured index of FDA premarket notifications built on openFDA regulatory metadata — device classifications, product codes, review panels, and 21 CFR citations — with direct links to official CDRH clearance summaries.
- Total Clearances
- 176,366
- Review Panels
- 21
- Coverage
- 1976-07-15 – 2026-10-02
Searches all 176,366 records live. Tip: enter a full K-number for an exact match.
Browse by Review Panel
Anesthesiology Cardiovascular Clinical Chemistry Clinical Toxicology Dental Ear, Nose, Throat Gastroenterology, Urology General Hospital General, Plastic Surgery Hematology Immunology Medical Genetics Microbiology Neurology Obstetrics/Gynecology Ophthalmic Orthopedic Pathology Physical Medicine Radiology Unknown