# K020003: Electrocardiograph (Ecg) Electrode, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Bio Protech, Inc.
- Decided: Nov 7, 2002 after 309 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 K982521 (1999). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982521: Skintact Ecg Electrodes, S&W Ecg Electrodes, Leonhard Lang Co. (1999) Summary page 2.

## Most influential descendants
- K040784: Protab Ecg Tabb Electrode (2004), 1 descendant of its own
- K090496: Qwiklead Reusable Electrocardiograph Electrode Patch (2009), 0 descendants of its own

## Indications for use
ECG electrodes are used to record the following ECGs from a patient: Resting ECG, Exercise ECG and/or ambulatory (Holter) monitoring. The intended patient population can be adult, pediatric and neonatal, while the environment of use can be hospital (or clinic), ambulance, or daily use environment (for Holter monitoring).

Source page: https://510kreport.com/device/K020003
Methodology: https://510kreport.com/methodology