Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
NON · 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) |
|---|---|---|---|---|---|
| K042648 | REPROCESSED COLD BIOPSY FORCEPS | Sterilmed, Inc. | 2005-07-20 | 295 | 1 |
| K042659 | MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS | Medisiss | 2005-02-14 | 139 | 0 |
| K042594 | VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS | Vanguard Medical Concepts, Inc. | 2005-01-25 | 124 | 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