# K192564: Disposable Gold Cup EEG Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Dymedix Diagnostics, Inc.
- Decided: Jan 21, 2020 after 125 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 K942921 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180232: DAEHAN Disposable CUP Electrodes, Daehan Medical Systems Co., Ltd. (2019) Summary page 5.
- K072016: Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable, Technomed Europe (2007) Summary page 5.

## Most influential descendants
- K213884: Disposable EEG cable (2022), 0 descendants of its own

## Indications for use
The Disposable Gold Cup EEG Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP).

Source page: https://510kreport.com/device/K192564
Methodology: https://510kreport.com/methodology