Cleared Traditional

K904002 - GENOX MODEL CT-1 OXYGEN/NITROGEN GENER-DISTR SYST

K904002 is an FDA 510(k) clearance for GENOX MODEL CT-1 OXYGEN/NITROGEN GENER-..., manufactured by Pacific Consolidated Industries. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K904002 · Pacific Consolidated Industries · Anesthesiology device
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Sep 1990
Decision
7d
Days
Class 2
Risk

K904002 is an FDA 510(k) clearance for the GENOX MODEL CT-1 OXYGEN/NITROGEN GENER-DISTR SYST. 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 Pacific Consolidated Industries (Orange, US). The FDA issued a Cleared decision on September 5, 1990 after a review of 7 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K904002

510(k) Number K904002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date September 05, 1990
Days to Decision 7 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 140d · This submission: 7d
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 228
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K904002.
PORTABLE OXYGEN GENERATOR
K915381 · Aequitron Medical, Inc. · Mar 1992
MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON
K904087 · Invacare Corp. · Oct 1990
V-LINK
K903608 · GE Medical Systems · Oct 1990
ASPEN 3 OXYGEN CONCENTRATOR
K902890 · Mountain Medical Equipment, Inc. · Jul 1990
DEVILBISS MODEL PV02 SERIES
K896457 · Devilbiss Health Care, Inc. · Feb 1990
PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR
K895177 · Puritan Bennett Corp. · Nov 1989
K904002 · GENOX MODEL CT-1 OXYGEN/NITROGEN GENER-DISTR SYST
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