FDA applicant

Maxtec, LLC

Salt Lake City, UT10 decisions2004–20230 recalls

FDA records 10 decisions for Maxtec, LLC (Salt Lake City, UT) from 2004 to 2023: 10 510(k) clearances. Most are in product codes CCL (Analyzer, Gas, Oxygen, Gaseous-Phase) and BZR (Mixer, Breathing Gases, Anesthesia Inhalation). Its devices cite 19 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Maxtec, Inc.”.

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

FDA decisions per year

2in 2023

2007high 2 (2016) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Maxtec, LLC

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?