Cleared Traditional

GOLEMB DISPOSABLE BAG MASK RESUSCITATOR (K973106) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 12
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K973106.
Disposable Manual Resuscitator
K210288 · Xiamen Compower Medical Tech. Co., Ltd. · Aug 2021
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
K181583 · Flexicare Medical Limited. · Dec 2018
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
K170663 · Foremount Enterprise Co., Ltd. · May 2018
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
K934699 · Respironics, Inc. · Jan 1995
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
K940581 · Respironics, Inc. · May 1994
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
K934310 · Respironics, Inc. · Dec 1993