Cleared Traditional

K053142 - AMBU MARK IV BABY RESUSCITATOR

K053142 is an FDA 510(k) clearance for AMBU MARK IV BABY RESUSCITATOR, manufactured by Ambu A/S. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K053142 · Ambu A/S · Anesthesiology device
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Dec 2005
Decision
41d
Days
Class 2
Risk

K053142 is an FDA 510(k) clearance for the AMBU MARK IV BABY RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Ambu A/S (Glen Burnie, US). The FDA issued a Cleared decision on December 20, 2005 after a review of 41 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 A/S devices

FDA 510(k) Submission Details - K053142

510(k) Number K053142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2005
Decision Date December 20, 2005
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
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 K053142.
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
K070247 · Ohmeda Medical · Apr 2007
RESUSCITATION TIMER, MODEL L770-CPR
K062080 · Allied Healthcare Products, Inc. · Oct 2006
AMBU MARK IV RESUSCITATOR
K053140 · Ambu A/S · Dec 2005
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
K042682 · Ambu, Inc. · Nov 2004
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
K042843 · Ambu, Inc. · Nov 2004
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
K023793 · Portex, Inc. · Feb 2003