Cleared Traditional

K953617 - RESPOSABLE RESUSCITATOR

K953617 is an FDA 510(k) clearance for RESPOSABLE 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 111-day FDA review.

K953617 · Medical Marketing Concepts · Anesthesiology device
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Nov 1995
Decision
111d
Days
Class 2
Risk

K953617 is an FDA 510(k) clearance for the RESPOSABLE RESUSCITATOR. 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 November 22, 1995 after a review of 111 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.

FDA 510(k) Submission Details - K953617

510(k) Number K953617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1995
Decision Date November 22, 1995
Days to Decision 111 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
29d faster than avg
Panel avg: 140d · This submission: 111d
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 K953617.
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
LIFEMASK FACE SHIELD
K953824 · Carefree Trading, Inc. · Sep 1995
CAPNO-FLO REGULATOR, CAPNO-FLO
K952512 · Kirk Specialty Systems · Aug 1995
SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
K952169 · Intertech Resources, Inc. · Jun 1995
K953617 · RESPOSABLE RESUSCITATOR
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