Keeler Optical Products , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Keeler Optical Products , Ltd.” (first 1978, latest 1981), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
| HPM | Locator, Metal, Electronic | 1 | 1 |
| HPS | Unit, Cryophthalmic | 1 | 1 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
| LCC | Applicator, Ocular Pressure | 1 | 1 |
Review panels
- Ophthalmic (5)
Most recent Keeler Optical Products , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K810403 | KEELER/KONAN SPECULAR MICROSCOPE | HJO | 1981-05-13 | 84 |
| K801418 | KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT | HPS | 1980-07-21 | 34 |
| K792255 | NEVYAS AUTOPRESS EYE COMPRESSOR | LCC | 1979-12-11 | 32 |
| K782141 | LEVIGATOR, KEELER PHOKO | HQC | 1979-01-26 | 30 |
| K781892 | LOCATOR, FOREIGN BODY | HPM | 1978-12-04 | 26 |
Recalls
openFDA lists no recalls under a recalling firm named Keeler Optical Products , Ltd..
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.
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.
- Keeler Instruments, Inc. (60 510(k)s)
- Keeler Limited (5 510(k)s)
- Keeler, Ltd. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Keeler Optical Products , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Keeler Optical Products , Ltd.” (first 1978, latest 1981), across 5 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 Keeler Optical Products , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Keeler Optical Products , Ltd. is 32 days.
Which FDA product codes appear under Keeler Optical Products , Ltd.?
The most frequent FDA product codes under this applicant name are HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 1); HPM (Locator, Metal, Electronic, 1); HPS (Unit, Cryophthalmic, 1).
Next steps
- See all 5 Keeler Optical Products , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HJO, Keeler Optical Products , Ltd.'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.