# K211839: Electrode Market Disposable Surface Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Electrode Market Co., Ltd.
- Decided: Jul 28, 2021 after 44 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: 2 generations back to K971914 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073532: Disposable Adhesive Surface Electrodes, Disc Electrodes, Technomed Europe (2008) Summary page 5.

## Indications for use
The Electrode Market Disposable Surface Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP). The electrodes are designed for single use.

Source page: https://510kreport.com/device/K211839
Methodology: https://510kreport.com/methodology