Cleared Abbreviated

K063044 - CARDIOBELT ELECTRODE BELT

K063044 is an FDA 510(k) clearance for CARDIOBELT ELECTRODE BELT, manufactured by Monebo Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Abbreviated 510(k) pathway after a 170-day FDA review.

K063044 · Monebo Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
170d
Days
Class 2
Risk

K063044 is an FDA 510(k) clearance for the CARDIOBELT ELECTRODE BELT. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Monebo Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on March 23, 2007 after a review of 170 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Monebo Technologies, Inc. devices

FDA 510(k) Submission Details - K063044

510(k) Number K063044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2006
Decision Date March 23, 2007
Days to Decision 170 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 125d · This submission: 170d
Pathway characteristics
Standards-based clearance path.

DRX Device Classification - Class 2, Special Controls

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 172
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K063044.
TELECTRODE WET GEL ECG ELECTRODE
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SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
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SKINTACT AND VARIOUS OTHER TRADENAMES
K073104 · Leonhard Lang GmbH · Nov 2007
AMBU WHITE SENSOR CFM, CFL
K052944 · Ambu A/S · Oct 2006
AMBU BLUE SENSOR NEO AND NEO X
K053550 · Ambu A/S · Oct 2006
MACTRODE 3
K060661 · Ge Medical Systems Information Technologies · Apr 2006