Cleared Traditional

K961329 - BAGRIGHT CHILD RESUSCITATOR

K961329 is an FDA 510(k) clearance for BAGRIGHT CHILD RESUSCITATOR, manufactured by Medical Marketing Concepts. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K961329 · Medical Marketing Concepts · Anesthesiology device
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Jul 1996
Decision
85d
Days
Class 2
Risk

K961329 is an FDA 510(k) clearance for the BAGRIGHT CHILD RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Medical Marketing Concepts (Roanoke, US). The FDA issued a Cleared decision on July 2, 1996 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Marketing Concepts devices

FDA 510(k) Submission Details - K961329

510(k) Number K961329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1996
Decision Date July 02, 1996
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 111
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K961329.
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
K970959 · Instrumentation Industries, Inc. · Jun 1997
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HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
K964719 · Hudson Respiratory Care, Inc. · Feb 1997
DMR/CO2 COMBO KTI
K960468 · Nellcor Puritan Bennett, Inc. · Apr 1996
SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
K952169 · Intertech Resources, Inc. · Jun 1995
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
K934699 · Respironics, Inc. · Jan 1995