FDA applicant

Arkray Factory, Inc.

Koka-Shi, JP6 decisions2014–20190 recalls

FDA records 6 decisions for Arkray Factory, Inc. (Koka-Shi, JP) from 2014 to 2019: 6 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and CGA (Glucose Oxidase, Glucose). Since 2016 its 510(k)s took a median of 219 days from receipt to decision, against 173 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No 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, clinical chemistry panel, where it files most

How often FDA has decided Arkray Factory, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2014high 3 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Arkray Factory, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Arkray Factory, Inc.’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

Other applicant names beginning “Arkray”

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

Arkray, Inc. 18 Arkray Factory USA, Inc. 9 Arkray USA, Inc. 1

Arkray Factory, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Arkray”