Cleared Traditional

K912620 - OPOMAT MANUAL RESUSCITATOR VENTILATOR

K912620 is an FDA 510(k) clearance for OPOMAT MANUAL RESUSCITATOR VENTILATOR, manufactured by Euro-Am Pharma, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K912620 · Euro-Am Pharma, Inc. · Anesthesiology device
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Dec 1991
Decision
174d
Days
Class 2
Risk

K912620 is an FDA 510(k) clearance for the OPOMAT MANUAL RESUSCITATOR VENTILATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Euro-Am Pharma, Inc. (Fanwood, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 174 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 Euro-Am Pharma, Inc. devices

FDA 510(k) Submission Details - K912620

510(k) Number K912620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1991
Decision Date December 04, 1991
Days to Decision 174 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
34d slower than avg
Panel avg: 140d · This submission: 174d
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 132
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K912620.
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PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
K920570 · Puritan Bennett Corp. · Feb 1992
V*CARE MANUAL RESUSCITATOR, CAT#VR-1000
K913900 · Ventlab Corp. · Jan 1992
EMS SINGLE USE MANUAL RESUSCITATORS
K912203 · Engineered Medical Systems · Nov 1991
AMBU SILICONE RESUSCITATOR INFANT/CHILD
K914187 · Ambu, Inc. · Oct 1991
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
K913370 · Puritan Bennett Corp. · Aug 1991