Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MCH · 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) |
|---|---|---|---|---|---|
| K040148 | RESOLUTION HEMOSTASIS CLIPPING DEVICE | Boston Scientific Corp | 2004-04-22 | 90 | 2 |
| K972745 | TITANIUM HEMOSTATIC CLIP | Eisner USA, Inc. | 1997-10-21 | 90 | 0 |
| K896998 | ATRAUCLIP (TANTALUM HEMOSTATIC CLIP) | S.P.K. Technology, Inc. | 1990-06-01 | 171 | 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