Cleared Traditional

K052944 - AMBU WHITE SENSOR CFM

K052944 is the FDA 510(k) clearance for AMBU WHITE SENSOR CFM by Ambu A/S. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 370-day FDA review.

K052944 · Ambu A/S · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2006
Decision
370d
Days
Class 2
Risk

K052944 is an FDA 510(k) clearance for the AMBU WHITE SENSOR CFM, CFL. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Ambu A/S (Glen Burnie, US). The FDA issued a Cleared decision on October 25, 2006 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ambu A/S devices

Submission Details

510(k) Number K052944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2005
Decision Date October 25, 2006
Days to Decision 370 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
245d slower than avg
Panel avg: 125d · This submission: 370d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 80
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K052944.
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
K100129 · Ambu A/S · Jun 2010
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K091856 · Conmed Corporation · Aug 2009
AMBU BLUE SENSOR NEO AND NEO X
K053550 · Ambu A/S · Oct 2006
MACTRODE 3
K060661 · Ge Medical Systems Information Technologies · Apr 2006
ECG ELECTRODE (VARIOUS)
K991105 · Conmedcorp · Nov 1999
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · Graphic Controls Corp. · Nov 1998