Cleared Traditional

K924216 - AMBU SILICONE RESUSCITATOR INFAN/CHILD ...

K924216 is an FDA 510(k) clearance for AMBU SILICONE RESUSCITATOR INFAN/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 43-day FDA review.

K924216 · Ambu, Inc. · Anesthesiology device
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Sep 1992
Decision
43d
Days
Class 2
Risk

K924216 is an FDA 510(k) clearance for the AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO. 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 September 16, 1992 after a review of 43 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 - K924216

510(k) Number K924216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1992
Decision Date September 16, 1992
Days to Decision 43 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
97d faster than avg
Panel avg: 140d · This submission: 43d
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 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K924216.
SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE
K923762 · Ambu, Inc. · Feb 1993
MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)
K913714 · Life Design Systems, Inc. · Dec 1992
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
K924215 · Ambu, Inc. · Sep 1992
SPUR ADULT WITH OPEN RESERVOIR SYSTEM
K922707 · Ambu, Inc. · Jun 1992
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
K922712 · Ambu, Inc. · Jun 1992
MODIFICATION PURITAN-BENNETT INFANT PM2
K922004 · Puritan Bennett Corp. · May 1992