510(k) Report

FDA applicant

Arkray USA, Inc.

Edina, MN1 decision2006–20060 recalls

FDA records 1 decision for Arkray USA, Inc. (Edina, MN) in 2006: 1 510(k) clearance. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). 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 USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arkray USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063068Ferrara Blood Glucose Monitoring System, Model 631100Arkray USA, Inc. · 20062cite it

What has FDA decided for it lately?

  • K063068Ferrara Blood Glucose Monitoring System, Model 631100Arkray USA, Inc. · 2006

The one decision as Arkray USA, Inc. →

Other applicant names beginning “Arkray”

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

Arkray, Inc. 18Arkray Factory USA, Inc. 9Arkray Factory, Inc. 6