Cleared Traditional

ACCUHEART ELECTRODE BELT (K043361) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043361 · Advanced Bioelectric Corporation · Cardiovascular device
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Mar 2005
Decision
105d
Days
Class 2
Risk

K043361 is an FDA 510(k) clearance for the ACCUHEART ELECTRODE BELT. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Advanced Bioelectric Corporation (Montreal, Qc, CA). The FDA issued a Cleared decision on March 22, 2005 after a review of 105 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Advanced Bioelectric Corporation devices

Submission Details

510(k) Number K043361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2004
Decision Date March 22, 2005
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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 19
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K043361.
MODEL 1300 SOFTRACE II ELECTRODE
K921164 · Medtronic Vascular · Mar 1993
MODEL 1850 ELECTRODE
K903918 · Medtronic Vascular · Oct 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · Medtronic Vascular · Jul 1990
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080 · 3M Company · Jul 1990
RED DOT CARDIAC SENSOR SYSTEM
K896155 · 3M Company · Dec 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · C.R. Bard, Inc. · Mar 1989