Cleared Traditional

K941145 - OXY-GENERATOR

K941145 is an FDA 510(k) clearance for OXY-GENERATOR, manufactured by Med Systems. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 566-day FDA review.

K941145 · Med Systems · Anesthesiology device
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Sep 1995
Decision
566d
Days
Class 2
Risk

K941145 is an FDA 510(k) clearance for the OXY-GENERATOR. 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 Med Systems (Santa Monica, US). The FDA issued a Cleared decision on September 27, 1995 after a review of 566 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Med Systems devices

FDA 510(k) Submission Details - K941145

510(k) Number K941145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1994
Decision Date September 27, 1995
Days to Decision 566 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
426d slower than avg
Panel avg: 140d · This submission: 566d
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 163
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K941145.
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
3 LPM OXYGEN CONCENTRATOR
K952037 · Devilbiss Health Care, Inc. · Sep 1995
H-500 ALLIANCE OXYGEN CONCENTRATOR
K942357 · Healthdyne, Inc. · May 1994
MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES
K924818 · Invacare Corp. · Aug 1993