510(k) Report

FDA applicant

Airon Corporation

Melbourne, FL4 decisions2003–20120 recalls

FDA records 4 decisions for Airon Corporation (Melbourne, FL) from 2003 to 2012: 4 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BTL (Ventilator, Emergency, Powered (Resuscitator)). Its devices cite 12 predicates, 4 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 Airon Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2008: 12012: 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 — Airon Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Airon Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use3decisions
  • BTLVentilator, Emergency, Powered (Resuscitator)1decision

Whose devices does it build on?

Its devices cite 12 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 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.

  • K043085Modification to: Pneuton VentilatorAiron Corporation · 20042cite it
  • K024344Pneuton VentilatorAiron Corporation · 20032cite it
  • K080692Macs Cpap SystemAiron Corporation · 20082cite it

What has FDA decided for it lately?

  • K121379Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit AccessoryAiron Corporation · 2012
  • K080692Macs Cpap SystemAiron Corporation · 2008
  • K043085Modification to: Pneuton VentilatorAiron Corporation · 2004
  • K024344Pneuton VentilatorAiron Corporation · 2003

All 4 as Airon Corporation →