Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GEF · 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) |
|---|---|---|---|---|---|
| K933508 | REFLEX SDD SURGICAL STAPLER | Richard-Allan Medical | 1993-11-23 | 126 | 0 |
| K915670 | MICROAIRE MODEL 2600 | Microaire | 1992-03-18 | 90 | 0 |
| K854568 | V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP | American V. Mueller | 1985-12-02 | 18 | 0 |
| K823888 | 3M FRASCIA STAPLING SYSTEM | 3M Company | 1983-01-09 | 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