Cleared Traditional

K914187 - AMBU SILICONE RESUSCITATOR INFANT/CHILD

K914187 is an FDA 510(k) clearance for AMBU SILICONE RESUSCITATOR INFANT/CHILD, manufactured by Ambu, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K914187 · Ambu, Inc. · Anesthesiology device
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Oct 1991
Decision
19d
Days
Class 2
Risk

K914187 is an FDA 510(k) clearance for the AMBU SILICONE RESUSCITATOR INFANT/CHILD. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on October 7, 1991 after a review of 19 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 Ambu, Inc. devices

FDA 510(k) Submission Details - K914187

510(k) Number K914187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1991
Decision Date October 07, 1991
Days to Decision 19 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
121d faster than avg
Panel avg: 140d · This submission: 19d
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 101
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K914187.
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
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
K913370 · Puritan Bennett Corp. · Aug 1991
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
K911971 · Puritan Bennett Corp. · Aug 1991
MOUTH TO MASK RESUSCITATOR
K912625 · Vital Signs, Inc. · Aug 1991