Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mentor O & O, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
166 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955245 | MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM | Mentor O & O, Inc. | 1996-02-12 | 89 | 0 |
| K934320 | MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GA | Mentor O & O, Inc. | 1994-02-16 | 166 | 1 |
| K912904 | MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM | Mentor O & O, Inc. | 1992-06-11 | 345 | 0 |
| K915340 | MENTOR HORIZON LOW VISION MAGNIFIER | Mentor O & O, Inc. | 1992-03-30 | 158 | 0 |
| K910637 | MENTOR(R) SUR-E-TROL(R) | Mentor O & O, Inc. | 1991-05-13 | 89 | 0 |
| K911160 | MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 | Mentor O & O, Inc. | 1991-05-02 | 48 | 1 |
| K903878 | MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT | Mentor O & O, Inc. | 1990-11-05 | 75 | 0 |
| K895010 | MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE | Mentor O & O, Inc. | 1989-09-11 | 34 | 0 |
| K890622 | SURG-E-TROL SYSTEM I AND SYSTEM II | Mentor O & O, Inc. | 1989-05-04 | 86 | 0 |
| K890595 | MENTOR ANTERIOR SEGMENT VITRECTOR | Mentor O & O, Inc. | 1989-04-17 | 70 | 0 |
| K881001 | MENTOR WET-FIELD*II COAGULATOR | Mentor O & O, Inc. | 1988-05-13 | 65 | 0 |
| K875112 | MENTOR B-VAT(TM) II VIDEO TESTER | Mentor O & O, Inc. | 1988-03-08 | 84 | 0 |
| K853736 | MENTOR BRIGHTNESS ACUITY TESTER | Mentor O & O, Inc. | 1985-11-01 | 56 | 0 |
| K853382 | MAID MENTOR ASPIRATION/IRRIGATION DEVRO | Mentor O & O, Inc. | 1985-10-04 | 53 | 0 |
| K850270 | CORNEAL LIGHT SHIELD | Mentor O & O, Inc. | 1985-05-31 | 128 | 0 |
| K844129 | SHURE GRIP TYING FORCEPS | Mentor O & O, Inc. | 1984-11-21 | 29 | 0 |
| K843304 | BINOCULAR INDIRECT OPHTHALMOSCOPE | Mentor O & O, Inc. | 1984-11-21 | 90 | 0 |
| K821932 | MENTOR POTENTIAL ACUITY METER | Mentor O & O, Inc. | 1982-08-03 | 35 | 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