Cleared Special

K060922 - OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5

K060922 is an FDA 510(k) clearance for OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, manufactured by Oxlife, LLC. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Special 510(k) pathway after a 56-day FDA review.

K060922 · Oxlife, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
56d
Days
Class 2
Risk

K060922 is an FDA 510(k) clearance for the OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5. 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 May 30, 2006 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K060922

510(k) Number K060922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2006
Decision Date May 30, 2006
Days to Decision 56 days
Submission Type Special
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
84d faster than avg
Panel avg: 140d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

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 K060922.
EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30
K061414 · Pacific Consolidated Industries, LLC · Jan 2007
PORTABLE OXYGEN GENERATOR SYSTEM
K062153 · Molecular Products , Ltd. · Nov 2006
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
DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES
K053240 · Sunrise Medical · Feb 2006