Cleared Traditional

SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE (K923762) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923762 · Ambu, Inc. · Anesthesiology device
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Feb 1993
Decision
192d
Days
Class 2
Risk

K923762 is an FDA 510(k) clearance for the SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE. 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 February 5, 1993 after a review of 192 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 Ambu, Inc. devices

Submission Details

510(k) Number K923762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date February 05, 1993
Days to Decision 192 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
52d slower than avg
Panel avg: 140d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K923762.
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)
K944347 · Puritan Bennett Corp. · Dec 1994
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
K940581 · Respironics, Inc. · May 1994
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
K934310 · Respironics, Inc. · Dec 1993
MODIFICATION PURITAN-BENNETT INFANT PM2
K922004 · Puritan Bennett Corp. · May 1992
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
K920570 · Puritan Bennett Corp. · Feb 1992
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
K913370 · Puritan Bennett Corp. · Aug 1991