# K043361: Accuheart Electrode Belt

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Bioelectric Corporation
- Decided: Mar 22, 2005 after 105 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K863116 (1986). 5 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960968: Medi-Trace 200, Medi-Trace 200-30, Graphic Controls Corp. (1996) Summary page 1.
- K982470: Ecg Electrodes Apron, Tapuz Medical Technology, Ltd. (1998) Summary page 1.

## Most influential descendants
- K063044: Cardiobelt Electrode Belt (2007), 18 descendants of its own
- K083309: Zargis Acoustic Cardioscan, Version 9.33 (2009), 14 descendants of its own
- K110704: SENSI (2011), 13 descendants of its own
- K121617: Sensicardiac (2012), 10 descendants of its own
- K131044: Sensicardiac Mobi Diagnostic Heart Murmur Application (2013), 9 descendants of its own

## Indications for use
The AccuHeartTM Electrode Belt is a reusable electrode system intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician. The AccuHeartTM Electrode Belt is compatible for use with most ECG instruments on the market.

Source page: https://510kreport.com/device/K043361
Methodology: https://510kreport.com/methodology