Cleared Traditional

K904639 - GENOX MODEL CT-1

K904639 is the FDA 510(k) clearance for GENOX MODEL CT-1 by Pacific Consolidated Industries. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K904639 · Pacific Consolidated Industries · Anesthesiology device
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Aug 1991
Decision
306d
Days
Class 2
Risk

K904639 is an FDA 510(k) clearance for the GENOX MODEL CT-1. 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 August 13, 1991 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pacific Consolidated Industries devices

Submission Details

510(k) Number K904639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date August 13, 1991
Days to Decision 306 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 140d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 67
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K904639.
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MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON
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V-LINK
K903608 · GE Medical Systems · Oct 1990
PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR
K895177 · Puritan Bennett Corp. · Nov 1989