FDA applicant

Arc Medical, Inc.

Clarkston, GA6 decisions1993–20090 recalls

FDA records 6 decisions for Arc Medical, Inc. (Clarkston, GA) from 1993 to 2009: 6 510(k) clearances. Most are in product codes CAH (Filter, Bacterial, Breathing-Circuit) and BTR (Tube, Tracheal (W/Wo Connector)). 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2009

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Arc Medical, 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?