Cleared Traditional

K864308 - BAUMAN CPR/RESPIRATOR

K864308 is the FDA 510(k) clearance for BAUMAN CPR/RESPIRATOR by General Medical Products, Inc.. It is a Class 2 Anesthesiology device (product code BTM) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K864308 · General Medical Products, Inc. · Anesthesiology device
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Mar 1987
Decision
126d
Days
Class 2
Risk

K864308 is an FDA 510(k) clearance for the BAUMAN CPR/RESPIRATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by General Medical Products, Inc. (Santa Monica, US). The FDA issued a Cleared decision on March 9, 1987 after a review of 126 days - within the typical 510(k) review window.

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 General Medical Products, Inc. devices

Submission Details

510(k) Number K864308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1986
Decision Date March 09, 1987
Days to Decision 126 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 140d · This submission: 126d
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 33
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K864308.
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
K900349 · Puritan Bennett Corp. · May 1990
RESPIRONICS INFANT BAGEASY
K895351 · Respironics, Inc. · Oct 1989
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
K894365 · Puritan Bennett Corp. · Oct 1989
STAT BLUE DISPOS. MANUAL RESUSCITATOR
K850436 · Vital Signs, Inc. · Feb 1985
RESPIRONICS VENTEASY
K842693 · Respironics, Inc. · Aug 1984
CODE BLUE MANUAL RESUSCITATOR
K831885 · Vital Signs, Inc. · Sep 1983