Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mentor Ophthalmics, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973146 | MENTOR SUPER ABSORBENT DRAPE | Mentor Ophthalmics, Inc. | 1997-12-04 | 104 | 0 |
| K971538 | MENTOR GEMINI HEMOSTATIC ERASER | Mentor Ophthalmics, Inc. | 1997-07-14 | 77 | 0 |
| K964312 | MENTOR TONO-PEN 3 | Mentor Ophthalmics, Inc. | 1996-11-26 | 28 | 0 |
| K960765 | MENTOR ADVENT A/B SYSTEM | Mentor Ophthalmics, Inc. | 1996-08-08 | 164 | 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