Cleared Traditional

K923762 - SPUR INFANT/CHILD W/O PRESSURE-LIMITING...

K923762 is an FDA 510(k) clearance for SPUR INFANT/CHILD W/O PRESSURE-LIMITING..., 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 192-day FDA review.

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

FDA 510(k) Submission Details - K923762

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
Combination Product No
PCCP Authorized No
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.

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 K923762.
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
AID, CARDIOPULMONARY RESUSCITATION
K930429 · Valley Forge Scientific Corp. · Mar 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
AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO
K924216 · Ambu, Inc. · Sep 1992