# K982470: Ecg Electrodes Apron

- Pathway: 510(k) (Traditional)
- Applicant: Tapuz Medical Technology, Ltd.
- Decided: Oct 14, 1998 after 90 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: 1 generation back to K863116 (1986). 3 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973663: Paljet-B, Golden Gate Bio-Device (1998) Summary page 2.
- K920627: Model Eli 100 Electrocardiograph, Mortara Instrument, Inc. (1992) Summary page 2.
- K863116: Cardiofax Ecg-6551 (Electrocardiogrph), Nihon Kohden America, Inc. (1986) Summary page 2.

## Most influential descendants
- K043361: Accuheart Electrode Belt (2005), 21 descendants of its own
- 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

## Indications for use
The ECG Electrodes Apron is a reusable electrode system intended for use in rest ECG recording. The ECG Electrodes Apron is compatible for use with most ECG instruments on the market.

Source page: https://510kreport.com/device/K982470
Methodology: https://510kreport.com/methodology