Cleared Traditional

K912203 - EMS SINGLE USE MANUAL RESUSCITATORS

K912203 is an FDA 510(k) clearance for EMS SINGLE USE MANUAL RESUSCITATORS, 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 177-day FDA review.

K912203 · Engineered Medical Systems · Anesthesiology device
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Nov 1991
Decision
177d
Days
Class 2
Risk

K912203 is an FDA 510(k) clearance for the EMS SINGLE USE MANUAL RESUSCITATORS. 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 November 13, 1991 after a review of 177 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.

View all Engineered Medical Systems devices

FDA 510(k) Submission Details - K912203

510(k) Number K912203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1991
Decision Date November 13, 1991
Days to Decision 177 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
37d slower than avg
Panel avg: 140d · This submission: 177d
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 84
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K912203.
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
K922712 · Ambu, Inc. · Jun 1992
MODIFICATION PURITAN-BENNETT INFANT PM2
K922004 · Puritan Bennett Corp. · May 1992
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
K920570 · Puritan Bennett Corp. · Feb 1992
AMBU SILICONE RESUSCITATOR INFANT/CHILD
K914187 · Ambu, Inc. · Oct 1991
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
K913370 · Puritan Bennett Corp. · Aug 1991
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
K911971 · Puritan Bennett Corp. · Aug 1991