FDA applicant

Arj Medical, Inc.

Oldsmar, FL4 decisions2006–20200 recalls

FDA records 4 decisions for Arj Medical, Inc. (Oldsmar, FL) from 2006 to 2020: 3 510(k) clearances and 1 original PMA approval. Most are in product codes KQO (Automated Urinalysis System) and OZA (Test, Urea Adult And Pediatric (Breath),). Its devices cite 1 predicate, 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 Arj Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Arj Medical, 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

Arj Medical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?