Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HBT · 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) |
|---|---|---|---|---|---|
| K924929 | REFLEX(R) ECA | Richard-Allan Medical | 1993-07-21 | 294 | 0 |
| K896262 | TITANIUM LIGATING CLIPS | Richard-Allan Medical Ind., Inc. | 1990-01-02 | 64 | 0 |
| K862696 | TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP | Downs Surgical , Ltd. | 1986-07-30 | 15 | 0 |
| K800318 | DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI | Edward Weck, Inc. | 1980-03-10 | 27 | 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