510(k) Report

FDA applicant

Airsonett AB

Fridley, MN2 decisions2008–20130 recalls

FDA records 2 decisions for Airsonett AB (Fridley, MN) from 2008 to 2013: 2 510(k) clearances. All are in product code FRF (Cleaner, Air, Medical Recirculating). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

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 Airsonett AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 12013: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Airsonett AB by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRFCleaner, Air, Medical Recirculating2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K081062Airsonnett Airshower Air 3Airsonett, Inc. · 20081cites it

What has FDA decided for it lately?

  • K130702Airsonett Air-4Airsonett AB · 2013
  • K081062Airsonnett Airshower Air 3Airsonett, Inc. · 2008

The one decision as Airsonett AB →The one decision as Airsonett, Inc. →