Cleared Traditional

K973106 - GOLEMB DISPOSABLE BAG MASK RESUSCITATOR

K973106 is an FDA 510(k) clearance for GOLEMB DISPOSABLE BAG MASK RESUSCITATOR, manufactured by Allied Healthcare Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K973106 · Allied Healthcare Products, Inc. · Anesthesiology device
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Jan 1998
Decision
163d
Days
Class 2
Risk

K973106 is an FDA 510(k) clearance for the GOLEMB DISPOSABLE BAG MASK RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Allied Healthcare Products, Inc. (Saint Louis, US). The FDA issued a Cleared decision on January 29, 1998 after a review of 163 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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 Allied Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K973106

510(k) Number K973106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1997
Decision Date January 29, 1998
Days to Decision 163 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 140d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K973106.
AMBU NEONATE SILICONE RESUSCITATOR
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RUSCH MANUAL RESUSCITATOR BAG
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K973419 · Nellcor Puritan Bennett, Inc. · Mar 1998
OHMEDA INFANT RESUSCITATION SYSTEM
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K972139 · Davis & Geck, Inc. · Sep 1997
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
K970959 · Instrumentation Industries, Inc. · Jun 1997