510(k) Report

FDA applicant

Aerus Medical, LLC

Dallas, TX1 decision2020–20200 recalls

FDA records 1 decision for Aerus Medical, LLC (Dallas, TX) in 2020: 1 510(k) clearance. All are in product code FRA (Purifier, Air, Ultraviolet, Medical). 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Aerus Medical, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRAPurifier, Air, Ultraviolet, Medical1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201220Aerus Medical Guardian,model F170AAerus Medical, LLC · 20201cites it

What has FDA decided for it lately?

  • K201220Aerus Medical Guardian,model F170AAerus Medical, LLC · 2020

The one decision as Aerus Medical, LLC →