Cleared Traditional

K080082 - OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS

K080082 is an FDA 510(k) clearance for OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS, manufactured by Oxlife, LLC. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K080082 · Oxlife, LLC · Anesthesiology device
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Apr 2008
Decision
96d
Days
Class 2
Risk

K080082 is an FDA 510(k) clearance for the OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS. 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 Oxlife, LLC (Hendersonville, US). The FDA issued a Cleared decision on April 16, 2008 after a review of 96 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 Oxlife, LLC devices

FDA 510(k) Submission Details - K080082

510(k) Number K080082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2008
Decision Date April 16, 2008
Days to Decision 96 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
44d faster than avg
Panel avg: 140d · This submission: 96d
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 K080082.
INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100
K083751 · Invacare Corporation · May 2009
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