Mentor O & O, Inc.: FDA clearances and approvals
Mentor O & O, Inc. has 18 FDA 510(k) clearances (first 1982, latest 1996), across 12 product codes in 3 review panels. Median 510(k) review time: 80 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HOX | Chart, Visual Acuity | 3 | 3 |
| HLI | Ophthalmoscope, Ac-Powered | 2 | 2 |
| HQC | Unit, Phacofragmentation | 2 | 2 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 | 2 |
| HQQ | Apparatus, Cautery, Radiofrequency, Battery-Powered | 2 | 2 |
| FRN | Pump, Infusion | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HJG | System, Reading, Television, Closed-Circuit | 1 | 1 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 | 1 |
| HNR | Forceps, Ophthalmic | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Mentor O & O, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955245 | MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM | HQC | 1996-02-12 | 89 |
| K934320 | MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION | HQR | 1994-02-16 | 166 |
| K912904 | MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM | HQC | 1992-06-11 | 345 |
| K915340 | MENTOR HORIZON LOW VISION MAGNIFIER | HJG | 1992-03-30 | 158 |
| K910637 | MENTOR(R) SUR-E-TROL(R) | FRN | 1991-05-13 | 89 |
| K911160 | MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 | GEI | 1991-05-02 | 48 |
| K903878 | MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT | HQQ | 1990-11-05 | 75 |
| K895010 | MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE | HLI | 1989-09-11 | 34 |
| K890622 | SURG-E-TROL SYSTEM I AND SYSTEM II | HQE | 1989-05-04 | 86 |
| K890595 | MENTOR ANTERIOR SEGMENT VITRECTOR | HKP | 1989-04-17 | 70 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mentor O & O, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Mentor O & O, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Mentor O & O, Inc. have?
Mentor O & O, Inc. has 18 FDA 510(k) clearances (first 1982, latest 1996), across 12 product codes in 3 review panels.
How long does FDA take to clear Mentor O & O, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mentor O & O, Inc.'s cleared 510(k)s is 80 days.
What devices does Mentor O & O, Inc. make?
Its most frequent FDA product codes are HOX (Chart, Visual Acuity, 3); HLI (Ophthalmoscope, Ac-Powered, 2); HQC (Unit, Phacofragmentation, 2).
Has Mentor O & O, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mentor O & O, Inc. Related entities may recall under other names.
Next steps
- See all 18 Mentor O & O, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HOX, Mentor O & O, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.