FDA applicant
Kowa Co., Ltd.
FDA records 19 decisions for Kowa Co., Ltd. (Chuo-Ku, Tokyo, JP) from 2005 to 2022: 19 510(k) clearances. Most are in product codes HKI (Camera, Ophthalmic, Ac-Powered) and HJO (Biomicroscope, Slit-Lamp, Ac-Powered). Its devices cite 18 predicates, 9 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Kowa Company , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Kowa Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Kowa Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Kowa”
FDA records each applicant name separately; these may or may not be the same firm.