510(k) Report

FDA applicant

Kowa Co. Ltd. Chofu

Chofu City, JP1 decision2019–20191 recall

FDA records 1 decision for Kowa Co. Ltd. Chofu (Chofu City, JP) in 2019: 1 510(k) clearance. All are in product code NFJ (System, Image Management, Ophthalmic). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Kowa Co. Ltd. Chofu’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2019high 1 (2020) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Kowa Co. Ltd. Chofu by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kowa Co. Ltd. Chofu’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) Report

Which product codes does it file in?

  • NFJSystem, Image Management, Ophthalmic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K190056KOWA VK-2sKowa Co. Ltd. Chofu · 20191 recall

The one decision as Kowa Co. Ltd. Chofu →

What has been recalled?

1 recall linked to its devices; the latest:

  • K190056Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa…Nov 3, 2020Class II

Other applicant names beginning “Kowa”

FDA records each applicant name separately; these may or may not be the same firm.

Kowa Co., Ltd. 19Kowa Optimed, Inc. 10Kowa Company, Ltd. Chofu Factory 1