# K142159: Disposable Pre-Gelled Surface Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Rochester Electro Medical, Inc.
- Decided: Jun 3, 2015 after 301 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 K941799 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110289: Friendship Medical Disposable Pre-Gelled AG / Agcl Surface Electrode, Xian Friendship Medical Electronics Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K172703: Disposable Snap Electrode (2017), 0 descendants of its own

## Indications for use
The Disposable Pre-gelled Surface Electrodes are intended for recording/stimulation and monitoring of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potential (EP) signals.

Source page: https://510kreport.com/device/K142159
Methodology: https://510kreport.com/methodology