Data / Medical devices / United States / Kowa Pharmaceuticals America, Inc.

Kowa Pharmaceuticals America, Inc.: FDA-registered device maker in Montgomery, AL, United States, 4 510(k) clearances

Name: Kowa Pharmaceuticals America, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Kowa Pharmaceuticals America, Inc. is registered with the FDA (registration 2080939) in Montgomery, AL, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 11, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2080939
Address: 530 Industrial Park Blvd, Montgomery, AL, United States, 36117
Owner or operator: Kowa Pharmaceuticals America, Inc. (2080939)
Roles: Complaint file establishment
First device listed: December 6, 2022
Registered through: 2026
Brand names listed: FM-600, KOWA APPLANATION TONOMETER HA-1; KOWA APPLANATION TONOMETER HA-2, KOWA DR-1a, SL-19

Devices it lists

Device	Product code	Class	Role	Source
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	2	Complaint file establishment	accessdata.fda.gov
Camera, Ophthalmic, Ac-Powered	HKI	2	Complaint file establishment	accessdata.fda.gov
Ophthalmoscope, Laser, Scanning	MYC	2	Complaint file establishment	accessdata.fda.gov
Tonometer, Manual	HKY	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 11, 2026	K261255	KOWA FM-600	MYC	Substantially Equivalent	Kowa Company, Ltd. Chofu Factory	accessdata.fda.gov
November 21, 2022	K222372	Kowa SL-19	HJO	Substantially Equivalent	Kowa Company , Ltd.	accessdata.fda.gov
June 4, 2019	K190573	KOWA DR-1a	HKI	Substantially Equivalent	Kowa Company , Ltd.	accessdata.fda.gov
June 4, 1996	K960924	KOWA HAND-HELD APPLANATION TONOMETER HA-1	HKY	Substantially Equivalent	Kowa Optimed, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 3, 2020	86737	Class II	Terminated	Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-m	It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a potential for all patient information to be deleted. This could result in delay of treatment.	accessdata.fda.gov

Compare with other makers

Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.