Cleared Traditional

K982215 - MANUAL RESUSCITATOR WITH ACE

K982215 is an FDA 510(k) clearance for MANUAL RESUSCITATOR WITH ACE, 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 87-day FDA review.

K982215 · Medical Marketing Concepts · Anesthesiology device
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Sep 1998
Decision
87d
Days
Class 2
Risk

K982215 is an FDA 510(k) clearance for the MANUAL RESUSCITATOR WITH ACE. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Medical Marketing Concepts (Crofton, US). The FDA issued a Cleared decision on September 18, 1998 after a review of 87 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 - K982215

510(k) Number K982215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1998
Decision Date September 18, 1998
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 110
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K982215.
RUSCH MANUAL RESUSCITATOR BAG
K993194 · Rusch, Inc. · Mar 2000
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
K991955 · Engineered Medical Systems · Jul 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
K991953 · Engineered Medical Systems · Jul 1999
CPR FILTERSHIELD
K980066 · Plasco, Inc. · Jul 1998
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
K981307 · International Respiratory Systems, Inc. · Jul 1998
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG
K981308 · International Respiratory Systems, Inc. · Jul 1998