Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DWH · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904352 | CODMAN COLLINS RADIOPARENT STERNAL BLADES | Codman & Shurtleff, Inc. | 1990-11-21 | 58 | 0 |
| K862474 | HALL STERNUM SAW | Hall Surgical, Division of Zimmer, Inc. | 1986-07-17 | 17 | 0 |
| K850483 | MICRO-AIRE STERNUM SAW REPLACEMENT BLADES | Micro-Aire Surgical Instruments, Inc. | 1985-03-01 | 22 | 0 |
| K830189 | CARDIOVASCULAR SAW BLADES | Temp Medical Products, Inc. | 1983-03-24 | 64 | 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