Cleared Abbreviated

K072688 - LIFECHOICE OXYGEN CONCENTRATOR

K072688 is an FDA 510(k) clearance for LIFECHOICE OXYGEN CONCENTRATOR, manufactured by International Biophysics Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Abbreviated 510(k) pathway after a 109-day FDA review.

K072688 · International Biophysics Corp. · Anesthesiology device
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Jan 2008
Decision
109d
Days
Class 2
Risk

K072688 is an FDA 510(k) clearance for the LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000. 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 International Biophysics Corp. (Austin, US). The FDA issued a Cleared decision on January 11, 2008 after a review of 109 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all International Biophysics Corp. devices

FDA 510(k) Submission Details - K072688

510(k) Number K072688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date January 11, 2008
Days to Decision 109 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 140d · This submission: 109d
Pathway characteristics
Standards-based clearance path.

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 K072688.
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K053230 · Merits Health Products Co., Ltd. · May 2006