Cleared Traditional

K952941 - SUN MODEL OA 3000 OXYGEN ANALYZER

K952941 is an FDA 510(k) clearance for SUN MODEL OA 3000 OXYGEN ANALYZER, manufactured by Sun Medical Equipment, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K952941 · Sun Medical Equipment, Inc. · Anesthesiology device
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Jan 1996
Decision
217d
Days
Class 2
Risk

K952941 is an FDA 510(k) clearance for the SUN MODEL OA 3000 OXYGEN ANALYZER. 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 Sun Medical Equipment, Inc. (Orlando, US). The FDA issued a Cleared decision on January 29, 1996 after a review of 217 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 Sun Medical Equipment, Inc. devices

FDA 510(k) Submission Details - K952941

510(k) Number K952941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1995
Decision Date January 29, 1996
Days to Decision 217 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
77d slower than avg
Panel avg: 140d · This submission: 217d
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 K952941.
INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853
K963042 · Sim Italia S.R.L. · Nov 1996
EMOX
K954506 · Medtrak Intl., Inc. · Apr 1996
OXLIFE OXYGEN CONCENTRATORS
K955549 · Oxlife, Inc. · Mar 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