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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 224
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K080082.
HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN
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HOMELOX
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DRIVE SOLSTICE OXYGEN CONCENTRATOR
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K071608 · Zhongshan A&J Medical Equipment Co., Ltd. · Jan 2008
LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000
K072688 · International Biophysics Corp. · Jan 2008