Cleared Traditional

K053140 - AMBU MARK IV RESUSCITATOR

K053140 is an FDA 510(k) clearance for AMBU MARK IV 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 44-day FDA review.

K053140 · Ambu A/S · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
44d
Days
Class 2
Risk

K053140 is an FDA 510(k) clearance for the AMBU MARK IV 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 23, 2005 after a review of 44 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.

FDA 510(k) Submission Details - K053140

510(k) Number K053140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2005
Decision Date December 23, 2005
Days to Decision 44 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
96d faster than avg
Panel avg: 140d · This submission: 44d
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 150
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K053140.
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
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HSINER RESUSCITATOR
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AMBU MARK IV BABY RESUSCITATOR
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PVC AND SILICONE MANUAL RESUSCITATORS
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K042556 · Enter Medical Corporation · Mar 2005