Cleared Traditional

K953546 - MANUAL PULMONARY RESUSICITATOR

K953546 is an FDA 510(k) clearance for MANUAL PULMONARY RESUSICITATOR, 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 216-day FDA review.

K953546 · Medical Marketing Concepts · Anesthesiology device
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Feb 1996
Decision
216d
Days
Class 2
Risk

K953546 is an FDA 510(k) clearance for the MANUAL PULMONARY RESUSICITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Medical Marketing Concepts (Hardy, US). The FDA issued a Cleared decision on February 29, 1996 after a review of 216 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.

FDA 510(k) Submission Details - K953546

510(k) Number K953546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1995
Decision Date February 29, 1996
Days to Decision 216 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
76d slower than avg
Panel avg: 140d · This submission: 216d
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 172
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K953546.
RESPOSABLE CHILD RESUSCITATOR
K961868 · Medical Marketing Concepts · Jun 1996
RESPOSABLE INFANT RESUSCITATOR
K961882 · Medical Marketing Concepts · Jun 1996
DMR/CO2 COMBO KTI
K960468 · Nellcor Puritan Bennett, Inc. · Apr 1996
MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR
K954866 · Mercury Medical · Jan 1996
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
K954150 · Green Field Medical Sourcing, Inc. · Dec 1995
BAGRIGHT RESUSCITATOR
K954296 · Medical Marketing Concepts · Dec 1995
K953546 · MANUAL PULMONARY RESUSICITATOR
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