Cleared Traditional

K910040 - AMBU SIR 2 (SILICONE RESUSCITATOR)

K910040 is an FDA 510(k) clearance for AMBU SIR 2 (SILICONE RESUSCITATOR), 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 144-day FDA review.

K910040 · Ambu, Inc. · Anesthesiology device
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May 1991
Decision
144d
Days
Class 2
Risk

K910040 is an FDA 510(k) clearance for the AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Ambu, Inc. (Hanover, US). The FDA issued a Cleared decision on May 28, 1991 after a review of 144 days - within the typical 510(k) review window.

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 - K910040

510(k) Number K910040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1991
Decision Date May 28, 1991
Days to Decision 144 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 140d · This submission: 144d
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 K910040.
VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
K904899 · Vital Signs, Inc. · Jul 1991
PRESSURE LIMITING ELBOW WITH MANOMETER PORT
K911298 · Intertech Resources, Inc. · Jun 1991
MANUAL RESUSCITATOR
K910856 · Vital Signs, Inc. · Jun 1991
1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR
K902733 · Intertech Resources, Inc. · Aug 1990
MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS
K903438 · Puritan Bennett Corp. · Aug 1990
MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR
K903443 · Puritan Bennett Corp. · Aug 1990