Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HQW — 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) |
|---|---|---|---|---|---|
| K897119 | GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP | Grieshaber & Co. | 1990-04-12 | 107 | 0 |
| K901275 | RETINAL TAAK | Alcon Surgical, Inc. | 1990-03-23 | 4 | 0 |
| K840207 | DOUBLE & SINGLE TANTALUM CLIPS | Storz Instrument Co. | 1984-03-29 | 70 | 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