Cleared Traditional

K071904 - DEPLOYABLE OXYGEN GENERATION SYSTEM - M...

K071904 is an FDA 510(k) clearance for DEPLOYABLE OXYGEN GENERATION SYSTEM - M..., manufactured by Carleton Life Support Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K071904 · Carleton Life Support Systems, Inc. · Anesthesiology device
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Oct 2007
Decision
107d
Days
Class 2
Risk

K071904 is an FDA 510(k) clearance for the DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M). Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Carleton Life Support Systems, Inc. (Davenport, US). The FDA issued a Cleared decision on October 25, 2007 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carleton Life Support Systems, Inc. devices

FDA 510(k) Submission Details - K071904

510(k) Number K071904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2007
Decision Date October 25, 2007
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAW Generator, Oxygen, Portable

All 121
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K071904.
PRECISION OXYGEN CONCENTRATOR
K072348 · Precision Medical, Inc. · Oct 2008
HOMELOX
K081206 · Respironics, Inc. · Jul 2008
THE INVACARE FLYER, MODEL IPC 100
K071928 · Invacare Corp. · Dec 2007
L4 OXYGEN CONCENTRATOR
K061261 · Respironics, Inc. · Jun 2006
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K053230 · Merits Health Products Co., Ltd. · May 2006
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K053229 · Merits Health Products Co., Ltd. · Mar 2006