Cleared Traditional

K941336 - COMBO MASK

K941336 is an FDA 510(k) clearance for COMBO MASK, manufactured by Gam Industries, Inc.. The device is a Class 1 Anesthesiology device with product code KGB cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K941336 · Gam Industries, Inc. · Anesthesiology device
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Sep 1994
Decision
172d
Days
Class 1
Risk

K941336 is an FDA 510(k) clearance for the COMBO MASK. Classified as Mask, Oxygen, Non-rebreathing (product code KGB), Class I - General Controls.

Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 172 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5570 - 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 Gam Industries, Inc. devices

FDA 510(k) Submission Details - K941336

510(k) Number K941336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date September 09, 1994
Days to Decision 172 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
32d slower than avg
Panel avg: 140d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

KGB Device Classification - Class 1, General Controls

Product Code KGB Mask, Oxygen, Non-rebreathing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5570
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGB Mask, Oxygen, Non-rebreathing

Devices cleared under the same product code (KGB) and FDA review panel - the closest regulatory comparables to K941336.
POCKET RESCUE
K970688 · Cheen Houng Ent. Co. , Ltd. · Sep 1997
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COMPACT MASK
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OXYGEN MASK W/RESERVOIR BAG
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OXYGEN MASK, CONCENTRATION AEROSOL MASK
K790162 · Airlife, Inc. · Apr 1979