Cleared Traditional

K954506 - EMOX

K954506 is an FDA 510(k) clearance for EMOX, manufactured by Medtrak Intl., Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K954506 · Medtrak Intl., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
215d
Days
Class 2
Risk

K954506 is an FDA 510(k) clearance for the EMOX. 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 Medtrak Intl., Inc. (Columbia, US). The FDA issued a Cleared decision on April 30, 1996 after a review of 215 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.

View all Medtrak Intl., Inc. devices

FDA 510(k) Submission Details - K954506

510(k) Number K954506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1995
Decision Date April 30, 1996
Days to Decision 215 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
75d slower than avg
Panel avg: 140d · This submission: 215d
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 148
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K954506.
OXYPURE PORTABLE OXYGEN GENERATOR
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OXLIFE OXYGEN CONCENTRATORS
K955549 · Oxlife, Inc. · Mar 1996
SUN MODEL OA 3000 OXYGEN ANALYZER
K952941 · Sun Medical Equipment, Inc. · Jan 1996
5 LPM OXYGEN CONCENTRATOR
K953815 · Devilbiss Health Care, Inc. · Nov 1995