Coburn Optical Ind., Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Coburn Optical Ind., Inc.” (first 1978, latest 1989), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 51 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 |
|---|---|---|---|
| HJG | System, Reading, Television, Closed-Circuit | 5 | 5 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 | 2 |
| GES | Blade, Scalpel | 1 | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 | 1 |
| HPJ | Instrument, Visual Field, Laser | 1 | 1 |
| HPT | Perimeter, Automatic, Ac-Powered | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
| HQG | Lens, Spectacle, Non-Custom (Prescription) | 1 | 1 |
Review panels
Most recent Coburn Optical Ind., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K892351 | MAGNILINK SYSTEM 602 | HJG | 1989-05-26 | 51 |
| K892350 | MAGNILINK SYSTEM 402/5 | HJG | 1989-05-26 | 51 |
| K892349 | MAGNILINK SYSTEM 209 | HJG | 1989-05-26 | 51 |
| K892348 | MAGNILINK SYSTEM 201 | HJG | 1989-05-26 | 51 |
| K892347 | MAGNILINK SYSTEM 101 | HJG | 1989-05-26 | 51 |
| K862188 | IRRIGATION & ASPIRATION/VITRECTOMY DEVICE | HQE | 1986-08-21 | 73 |
| K853457 | COBURN I/A SYSTEM | HQE | 1985-10-15 | 60 |
| K821737 | DISP. MICROSURGICAL KNIVES | GES | 1982-07-02 | 18 |
| K812441 | DI-CROWN | HQG | 1981-10-06 | 41 |
| K803159 | AUTOMATED PERIMETERS | HPT | 1981-02-04 | 58 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coburn Optical Ind., 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Coburn Optical Ind., Inc.?
FDA lists 14 510(k) clearances under the applicant name “Coburn Optical Ind., Inc.” (first 1978, latest 1989), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Coburn Optical Ind., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coburn Optical Ind., Inc. is 51 days.
Which FDA product codes appear under Coburn Optical Ind., Inc.?
The most frequent FDA product codes under this applicant name are HJG (System, Reading, Television, Closed-Circuit, 5); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 2); GES (Blade, Scalpel, 1).
Next steps
- See all 14 Coburn Optical Ind., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HJG, Coburn Optical Ind., 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.