Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Komet Medical — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991625 | KOMET XK-95 PERFORATOR MOTOR (MI-102) | Komet Medical | 1999-07-30 | 80 | 0 |
| K984035 | XK-95 HIGH SPEED MOTOR DRILL SYSTEM | Komet Medical | 1999-06-03 | 203 | 0 |
| K943758 | SURGICAL BUR | Komet Medical | 1994-08-22 | 20 | 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