Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Menicon U.S.A., Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000133 | MENICON Z | Menicon U.S.A., Inc. | 2000-05-19 | 122 | 0 |
| K972443 | MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS | Menicon U.S.A., Inc. | 1997-08-22 | 53 | 0 |
| K970019 | MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS | Menicon U.S.A., Inc. | 1997-03-25 | 82 | 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