Cleared Special

K042262 - INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10

K042262 is an FDA 510(k) clearance for INTEGRA OXYGEN CONCENTRATOR, manufactured by Sequal Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Special 510(k) pathway after a 18-day FDA review.

K042262 · Sequal Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
18d
Days
Class 2
Risk

K042262 is an FDA 510(k) clearance for the INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10. 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 Sequal Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on September 10, 2004 after a review of 18 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 - K042262

510(k) Number K042262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2004
Decision Date September 10, 2004
Days to Decision 18 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
122d faster than avg
Panel avg: 140d · This submission: 18d
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 K042262.
HOME-AWAY SYSTEM, MODEL 1041
K042944 · In-X Corporation · Apr 2005
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600
K043006 · Respironics, Inc. · Feb 2005
OXYTEC, MODEL 900
K043615 · Oxytec Medical Corporation · Feb 2005
PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C
K041664 · On Site Gas Systems, Inc. · Jul 2004
INOGEN ONE OXYGEN CONCENTRATOR
K032818 · Inogen, Inc. · May 2004
MOBILE OXYGEN STORAGE TANK (MOST)
K040738 · Pacific Consolidated Industries Llp · Apr 2004