FDA applicant

Arkray, Inc.

Cortlandt Manor, NY18 decisions2002–20243 recalls

FDA records 18 decisions for Arkray, Inc. (Cortlandt Manor, NY) from 2002 to 2024: 18 510(k) clearances. Most are in product codes JIL (Method, Enzymatic, Glucose (Urinary…) and KQO (Automated Urinalysis System). Its devices cite 13 predicates, 3 of them its own earlier devices. 3 recalls are linked to its devices, 2 Class I.

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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007high 2 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Arkray, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Arkray”

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

Arkray Factory USA, Inc. 9 Arkray Factory, Inc. 6 Arkray USA, Inc. 1

Arkray, 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?

What has been recalled?

Other applicant names beginning “Arkray”