Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Key Medical, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K821127 | KEY DRILL | Key Medical, Inc. | 1982-06-03 | 44 | 0 |
| K812760 | HI-TEMP CARDIOVASCULAR CAUTERY | Key Medical, Inc. | 1982-01-18 | 109 | 0 |
| K812644 | REPLACEABLE BATTERY PERFECTEMP 2 CAUT | Key Medical, Inc. | 1981-10-26 | 39 | 0 |
| K810909 | MICRO CAUTERY | Key Medical, Inc. | 1981-04-17 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda