Cleared Traditional

K991953 - MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION

K991953 is an FDA 510(k) clearance for MODIFICATION TO ENGINEERED MEDICAL SYST..., manufactured by Engineered Medical Systems. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K991953 · Engineered Medical Systems · Anesthesiology device
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Jul 1999
Decision
30d
Days
Class 2
Risk

K991953 is an FDA 510(k) clearance for the MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WIT.... Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Engineered Medical Systems (Indianapolis, US). The FDA issued a Cleared decision on July 1, 1999 after a review of 30 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 Engineered Medical Systems devices

FDA 510(k) Submission Details - K991953

510(k) Number K991953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1999
Decision Date July 01, 1999
Days to Decision 30 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
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 142
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K991953.
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
K991861 · Sims Portex, Inc. · Jan 2000
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
K992057 · Sims Portex, Inc. · Sep 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
K991955 · Engineered Medical Systems · Jul 1999
MANUAL RESUSCITATOR WITH ACE
K982215 · Medical Marketing Concepts · Sep 1998
CPR FILTERSHIELD
K980066 · Plasco, Inc. · Jul 1998
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
K981307 · International Respiratory Systems, Inc. · Jul 1998