510(k) Report

FDA applicant

Aerocrine AB

Solna, SE6 decisions2003–20150 recalls

FDA records 6 decisions for Aerocrine AB (Solna, SE) from 2003 to 2015: 5 510(k) clearances and 1 De Novo grant. All are in product code MXA (System, Test, Breath Nitric Oxide). Its devices cite 5 predicates, 5 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, clinical toxicology panel, where it files most

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

FDA decisions per year

1in 2015

2008: 12010: 12012: 12014: 12015: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MXASystem, Test, Breath Nitric Oxide6decisions

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K072816Niox MinoAerocrine AB · 20082cite it
  • K101034Niox Mino Model 09-1000Aerocrine AB · 20102cite it
  • DEN030001Niox Article NO: 02-1000Aerocrine AB · 20031cites it
  • K150233NIOX VERO Airway Inflammation MonitorAerocrine AB · 20151cites it
  • K133898Niox Vero Airway Inflammation MonitorAerocrine AB · 20141cites it

What has FDA decided for it lately?

  • K150233NIOX VERO Airway Inflammation MonitorAerocrine AB · 2015
  • K133898Niox Vero Airway Inflammation MonitorAerocrine AB · 2014
  • K123683Niox Panel for Use with the Niox Mino Airway Inflammation MonitorAerocrine AB · 2012
  • K101034Niox Mino Model 09-1000Aerocrine AB · 2010
  • K072816Niox MinoAerocrine AB · 2008
  • DEN030001Niox Article NO: 02-1000Aerocrine AB · 2003

All 6 as Aerocrine AB →