Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HFD · 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) |
|---|---|---|---|---|---|
| K891037 | WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | 17 | 0 |
| K890376 | VAGINAL SPECULUM | Kinetic Medical Products | 1989-02-27 | 35 | 0 |
| K810558 | SKIN SCRUB TRAY | Associated Medical Products Co. | 1981-03-17 | 15 | 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