Ocular Instruments, Inc.: FDA filings under this applicant name
FDA lists 50 510(k) clearances under the applicant name “Ocular Instruments, Inc.” (first 1984, latest 2002), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 58 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 25 | 25 |
| HKS | Prism, Gonioscopic | 7 | 7 |
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | 6 | 6 |
| HNH | Ring, Ophthalmic (Flieringa) | 5 | 5 |
| MLP | Keratoprosthesis, Temporary Implant, Surgical Use | 3 | 3 |
| HJI | Lens, Fundus, Hruby, Diagnostic | 1 | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
| HNJ | Punch, Corneo-Scleral | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
Review panels
- Ophthalmic (50)
Most recent Ocular Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K014170 | STAURENGHI WIDE FIELD SCANNING LASER LENS | HJK | 2002-03-04 | 74 |
| K012096 | DISPOSABLE VITRECTOMY LENS | HJK | 2001-08-24 | 50 |
| K933976 | MANDELKORN SUTURE LYSIS LENS | HJK | 1994-11-08 | 452 |
| K933264 | RITCH NYLON SUTURE LASER LENS | HJK | 1994-10-31 | 482 |
| K941420 | 50 DEGREE HRI PRISM LENS | HJK | 1994-08-29 | 159 |
| K935302 | OSHER SURGICAL GONIO/POSTERIOR POLE LENS | HKS | 1994-04-01 | 150 |
| K923670 | BYRNE EXPULSIVE LENS | HJI | 1992-11-16 | 117 |
| K921414 | TROKEL /3 GONIO LASER LENS | LQJ | 1992-11-16 | 237 |
| K914051 | PEDIATRIC VITRECTOMY LENS SET | HJK | 1991-12-09 | 90 |
| K914117 | LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET | HJK | 1991-11-13 | 61 |
40 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ocular Instruments, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ocular Instruments, Inc. (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via MLP)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via MLP)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via MLP)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ocular Sciences Puerto Rico, Inc. (7 510(k)s)
- Ocular Blood Flow Laboratories, Inc. (2 510(k)s)
- Ocular Innovations, Inc. (2 510(k)s)
- Ocular Sciences, Inc. (2 510(k)s)
- Ocular Therapeutix, Inc. (1 510(k)s)
- Ocular Concepts, LLC (1 510(k)s)
- Ocular Pharmaceuticals, Inc. (1 510(k)s)
- Ocular Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ocular Instruments, Inc.?
FDA lists 50 510(k) clearances under the applicant name “Ocular Instruments, Inc.” (first 1984, latest 2002), across 9 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ocular Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ocular Instruments, Inc. is 58 days.
Which FDA product codes appear under Ocular Instruments, Inc.?
The most frequent FDA product codes under this applicant name are HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic, 25); HKS (Prism, Gonioscopic, 7); LQJ (Lens, Surgical, Laser, Accesssory, Ophthalmic Laser, 6).
Next steps
- See all 50 Ocular Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HJK, Ocular Instruments, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.