Cleared Traditional

K954271 - WESTMED CONDESATE COLLECTION TRAP

K954271 is an FDA 510(k) clearance for WESTMED CONDESATE COLLECTION TRAP, manufactured by Westmed Intl.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K954271 · Westmed Intl. · Anesthesiology device
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Dec 1995
Decision
107d
Days
Class 2
Risk

K954271 is an FDA 510(k) clearance for the WESTMED CONDESATE COLLECTION TRAP. 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 Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 107 days - within the typical 510(k) review window.

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 Westmed Intl. devices

FDA 510(k) Submission Details - K954271

510(k) Number K954271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1995
Decision Date December 28, 1995
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
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 170
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K954271.
EMOX
K954506 · Medtrak Intl., Inc. · Apr 1996
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
ECO CHECK (ECOVALVE AND OXYGEN MONITOR)
K951882 · Airsep Corp. · Oct 1995
HUMIDIFIER & ACCESSORIES
K953949 · Fisher & Paykel Electronics , Ltd. · Oct 1995