Kowa Optimed, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Kowa Optimed, Inc.” (first 1988, latest 2002), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 68 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 | 3 | 3 |
| HKI | Camera, Ophthalmic, Ac-Powered | 3 | 3 |
| HPT | Perimeter, Automatic, Ac-Powered | 2 | 2 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| HKY | Tonometer, Manual | 1 | 1 |
Review panels
- Ophthalmic (10)
Most recent Kowa Optimed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013805 | KOWA AUTOMATED TONOMETER KT-500 | HKX | 2002-10-11 | 330 |
| K961090 | AUTOMATIC VISUAL FIELD PLOTTER AP-125 | HPT | 1996-06-17 | 90 |
| K960924 | KOWA HAND-HELD APPLANATION TONOMETER HA-1 | HKY | 1996-06-04 | 90 |
| K955442 | KOWA SC-1200 PHOTO SLIT LAMP SYSTEM | HKI | 1996-01-03 | 36 |
| K954781 | KOWA GENESIS HAND-HELD FUNDUS CAMERA | HKI | 1995-12-01 | 45 |
| K954780 | KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C | HKI | 1995-12-01 | 45 |
| K954782 | KOWA PORTABLE SLIT LAMP SL-14 & SL-14B | HJO | 1995-11-24 | 38 |
| K913852 | LASER FLARE METER | HJO | 1992-02-07 | 164 |
| K880920 | LASER FLARE CELL METER FC-1000 | HJO | 1988-09-27 | 207 |
| K881219 | AUTOMATIC PERIMETER, AP-340 | HPT | 1988-05-03 | 42 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-11-03.
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.
- Kowa Co. , Ltd. (16 510(k)s)
- Kowa Company , Ltd. (3 510(k)s)
- Kowa Co. Ltd. Chofu (1 510(k)s)
- Kowa Company, Ltd. Chofu Factory (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kowa Optimed, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Kowa Optimed, Inc.” (first 1988, latest 2002), 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 Kowa Optimed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kowa Optimed, Inc. is 68 days.
Which FDA product codes appear under Kowa Optimed, Inc.?
The most frequent FDA product codes under this applicant name are HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 3); HKI (Camera, Ophthalmic, Ac-Powered, 3); HPT (Perimeter, Automatic, Ac-Powered, 2).
Next steps
- See all 10 Kowa Optimed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HJO, Kowa Optimed, 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.