# K080276: Self-Adhesive Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Cathay Health Care Equipment Manufacturing, Inc.
- Decided: Aug 4, 2008 after 182 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903402 (1990). 6 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020735: Sof-Pach Reusable Neurostimulation Electrodes, Cathay International, Ltd. (2002) Summary page 1.
- K070612: Top-Rank Adhesive Electrode, Top-Rank Health Care Equipment Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K090198: Jiajian Self-Adhesive Electrode (2009), 26 descendants of its own
- K132998: Wandy Self-Adhesive Electrodes (2013), 16 descendants of its own
- K160138: Adhesive Electrodes (2016), 15 descendants of its own
- K180865: ZMI Self-Adhesive Electrodes (2018), 9 descendants of its own
- K222252: Self-adhesive Electrode (2023), 6 descendants of its own

## Indications for use
The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals

Source page: https://510kreport.com/device/K080276
Methodology: https://510kreport.com/methodology