510(k) Report

FDA applicant

Carleton Life Support Systems, Inc.

Davenport, IA3 decisions2005–20081 recall

FDA records 3 decisions for Carleton Life Support Systems, Inc. (Davenport, IA) from 2005 to 2008: 3 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and OLF (Medevac Use Oxygen Generator). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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 Carleton Life Support Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Carleton Life Support Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carleton Life Support Systems, Inc.’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, Portable2decisions
  • OLFMedevac Use Oxygen Generator1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K082829Aircraft Medical Oxygen Generation System (Amogs)Carleton Life Support Systems, Inc. · 20081 recall
  • K071904Deployable Oxygen Generation System - Medium (Dogs-M)Carleton Life Support Systems, Inc. · 2007
  • K051887Patient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF)Carleton Life Support Systems, Inc. · 2005

All 3 as Carleton Life Support Systems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K082829Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator…Jul 24, 2009