# K213884: Disposable EEG cable

- Pathway: 510(k) (Abbreviated)
- Applicant: Shenzhen Changke Connect Electronics Co., Ltd.
- Decided: May 6, 2022 after 144 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: 4 generations back to K942921 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192564: Disposable Gold Cup EEG Electrodes, Dymedix Diagnostics, Inc. (2020) Summary page 4.

## Indications for use
The Disposable EEG cable is 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/K213884
Methodology: https://510kreport.com/methodology