Cleared Traditional

K003472 - INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM

K003472 is an FDA 510(k) clearance for INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM, manufactured by Sequal Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K003472 · Sequal Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
208d
Days
Class 2
Risk

K003472 is an FDA 510(k) clearance for the INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM. 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 June 4, 2001 after a review of 208 days - an extended review cycle.

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 - K003472

510(k) Number K003472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2000
Decision Date June 04, 2001
Days to Decision 208 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
68d slower than avg
Panel avg: 140d · This submission: 208d
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 K003472.
HOME-AWAY SYSTEM
K004047 · In-X Corp. · Dec 2001
TOTAL O2
K013472 · Chad Therapeutics, Inc. · Nov 2001
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K011844 · Merits Health Products., Inc. · Aug 2001
VENTURE HOME FILL II, MODEL IOH 200
K003939 · Invacare Corp. · Mar 2001
DEVILBISS 5 LITER OXYGEN CONCENTRATOR
K991722 · Sunrise Medical Hhg, Inc. · Nov 1999
VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
K983627 · Invacare Corp. · Oct 1999