FDA applicant

Arkray Factory USA, Inc.

Edina, MN9 decisions2007–20110 recalls

FDA records 9 decisions for Arkray Factory USA, Inc. (Edina, MN) from 2007 to 2011: 9 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and CGA (Glucose Oxidase, Glucose). Its devices cite 6 predicates, 0 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 USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 4 (2009) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Arkray Factory USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Arkray Factory USA, 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, Inc. 6 Arkray USA, Inc. 1

Arkray Factory USA, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Arkray”