Sources
- FDA's list of AI-enabled medical devices (through 2026-06-29).
- openFDA 510(k), De Novo and PMA records for review time, pathway, product code, class and regulation.
How we join and check
Each FDA list entry is matched to its openFDA record by submission number. Current QA: 1,614 of 1,614 joined; 0 duplicates; 2 product-code mismatches and 1 date mismatch logged and flagged, not hidden; 34 text-encoding fixes.
By pathway
| Pathway | Devices |
|---|---|
| 510(k) | 1,553 |
| De Novo | 40 |
| PMA | 17 |
| PMA supplement | 4 |
Limits
- FDA's list currently runs only through 2026-06-29 and FDA says it is not comprehensive.
- No predicate-device data yet.
- Change-control-plan (PCCP) detection uses device names only, so it undercounts.
- Company names are not normalized.
- Review time is calendar days, not FDA review clock.