510(k)Explorer

Navigate the FDA 510(k) predicate chain like never before. 510(k) Predicate Explorer gives regulatory professionals, consultants, and device makers a fast, visual way to research substantial equivalence. Search across 99,000+ FDA clearances and instantly map how any device traces back through its predicate history — spanning decades and product generations. SEARCH Find any cleared device by K-number, device name, or company. Results are ranked newest first, so the most relevant clearances surface immediately. GRAPH VIEW Explore predicate relationships as an interactive network. Drag nodes, pinch to zoom, and tap any device to see its clearance details, indications for use, and which other devices cite it as a predicate. TIMELINE VIEW See the full predicate lineage plotted on a proportional time axis. Each generation of predicates appears in its own row, positioned by the actual year of clearance — so a chain spanning 1987 to 2024 tells its story at a glance. Ideal for spotting decade-long lineages, identifying technological turning points, and understanding how a device family evolved. DEVICE DETAILS For every node in the graph or timeline: K-number, device name, applicant, indications for use, full predicate list, and a list of all later devices that cited it. One tap opens the official FDA 510(k) summary PDF. ALWAYS CURRENT Refresh directly from the FDA database to pull in the latest clearances. The bundled dataset covers all submissions on record; the refresh adds new entries as they are cleared. WHO IT'S FOR • Regulatory affairs professionals building 510(k) submissions • RA consultants benchmarking predicate strategies • Medical device companies scoping competitive landscape • Investors conducting regulatory due diligence • Researchers studying the history of medical device clearances