FDA applicant

Automedx, Inc.

Germantown, MD2 decisions2007–20140 recalls

FDA records 2 decisions for Automedx, Inc. (Germantown, MD) from 2007 to 2014: 2 510(k) clearances. All are in product code BTL (Ventilator, Emergency, Powered (Resuscitator)). Its devices cite 3 predicates, 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2014

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Automedx, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?