Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HWM — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874503 | MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER | Micro-Aire Surgical Instruments, Inc. | 1987-12-02 | 30 | 0 |
| K870780 | ACROMED WALLIE-HEINIG OSTEOTOMES | Buckman Co., Inc. | 1987-03-09 | 11 | 0 |
| K771744 | OSTEOTOMES FOR CUTTING BONH | Depuy, Inc. | 1977-09-28 | 13 | 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