Kowa Co. , Ltd.: FDA clearances and approvals
Kowa Co. , Ltd. has 16 FDA 510(k) clearances (first 2005, latest 2014), across 4 product codes in 1 review panel. Median 510(k) review time: 100 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 188 |
| 2013 | 0 | — |
| 2014 | 1 | 92 |
| 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 |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | 12 | 12 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | 2 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| MYC | Ophthalmoscope, Laser, Scanning | 1 | 1 |
Review panels
- Ophthalmic (16)
Most recent Kowa Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133755 | KOWA SL-17 | HJO | 2014-03-11 | 92 |
| K112330 | KOWA VX-20 | HKI | 2012-02-16 | 188 |
| K101628 | KOWA NONMYD WX | HKI | 2011-01-26 | 230 |
| K091098 | KOWAGENESIS-DF | HKI | 2009-08-07 | 113 |
| K091039 | KOWA, FM-600, MODEL LSS50 | MYC | 2009-08-07 | 116 |
| K091683 | KOWA VX-10 A | HKI | 2009-07-02 | 22 |
| K083387 | MODIFICATION TO KOWA NONMYD ALPHA-DIII | HKI | 2009-01-16 | 60 |
| K082767 | KOWA NONMYD ALPHA-DIII | HKI | 2008-10-21 | 29 |
| K080681 | KOWA GENESIS-D | HKI | 2008-04-04 | 25 |
| K063640 | KOWA SL-15 | HJO | 2006-12-18 | 11 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kowa Co. , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances does Kowa Co. , Ltd. have?
Kowa Co. , Ltd. has 16 FDA 510(k) clearances (first 2005, latest 2014), across 4 product codes in 1 review panel.
How long does FDA take to clear Kowa Co. , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Kowa Co. , Ltd.'s cleared 510(k)s is 100 days.
What devices does Kowa Co. , Ltd. make?
Its most frequent FDA product codes are HKI (Camera, Ophthalmic, Ac-Powered, 12); HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 2); HKX (Tonometer, Ac-Powered, 1).
Has Kowa Co. , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kowa Co. , Ltd. Related entities may recall under other names.
Next steps
- See all 16 Kowa Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HKI, Kowa Co. , Ltd.'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.