510(k) Report

FDA applicant

Airsep Corp.

Buffalo, NY19 decisions1987–20153 recalls

FDA records 19 decisions for Airsep Corp. (Buffalo, NY) from 1987 to 2015: 19 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and CAF (Nebulizer (Direct Patient Interface)). Its devices cite 4 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Airsep Corporation”.

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 Airsep Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008: 12011: 12015: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2024

2013: 12024: 2
2007high 2 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Airsep Corp.’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?

  • CAWGenerator, Oxygen, Portable8decisions
  • CAFNebulizer (Direct Patient Interface)2decisions
  • NFBConserver, Oxygen2decisions
  • OLVStandard Polysomnograph With Electroencephalograph2decisions
  • FLSMonitor, Apnea, Facility Use1decision
  • GWEStimulator, Photic, Evoked Response1decision

Also: DQA (1), BZD (1), GWF (1).

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 1 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.

  • K020324Lifestyle Oxygen ConcentratorAirsep Corp. · 20025cite it
  • K150930Deployable Oxygen Generation System-Smaill (DOGS-S)Airsep Corporation · 20153cite it
  • K962865Rembrandt SystemAirsep Corp. · 19963cite it
  • K960309Airsep Newlife Dual Six Oxygen Concentrator (Modification)Airsep Corp. · 19972cite it
  • K992283Artisan Acquisition System for Eeg and PolysomnographyAirsep Corp. · 19991cites it
  • K001013Monet Acquisition System for Eeg and PolysomnographyAirsep Corp. · 20001cites it

What has FDA decided for it lately?

  • K150930Deployable Oxygen Generation System-Smaill (DOGS-S)Airsep Corporation · 2015
  • K101154Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-LAirsep Corp. · 2011
  • K080348Oxiscan II Data Management SystemAirsep Corp. · 2008
  • K020324Lifestyle Oxygen ConcentratorAirsep Corp. · 20023 recalls
  • K012037Healthlife Oxygen Concentrator Model AS009Airsep Corp. · 2002
  • K000963DA Vinchi Eeg and Emg/EP SystemsAirsep Corp. · 2000
  • K001579Impulse SelectAirsep Corp. · 2000
  • K001467DA Vinchi Emg/EP ISA1004EPAirsep Corp. · 2000

All 18 as Airsep Corp. →The one decision as Airsep Corporation →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K020324CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.Oct 4, 2024Class II
  • K020324CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.Oct 4, 2024Class II
  • K020324Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also…Jan 14, 2013Class II