# K110289: Friendship Medical Disposable Pre-Gelled AG / Agcl Surface Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Xian Friendship Medical Electronics Co., Ltd.
- Decided: Aug 30, 2011 after 210 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 K941799 (1995). 5 ancestors in all.
2 later devices descend 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)
- K062198: Sunspots Pre-Gelled Surface Electrodes, Axon Systems, Inc. (2006) Summary page 1.
- K052188: Cutaneous Electrode, Rhythmlink International, LLC (2005) Summary page 1.

## Most influential descendants
- K142159: Disposable Pre-Gelled Surface Electrode (2015), 1 descendant of its own
- K172703: Disposable Snap Electrode (2017), 0 descendants of its own

## Indications for use
Disposable Pre-gelled Ag/AgCI Surface Electrodes are intended for recording/stimulation and monitoring of the Electromygraphy (EMVG), Electroencephalograph(EEG) and Evoked Potential(EP) signals.

Source page: https://510kreport.com/device/K110289
Methodology: https://510kreport.com/methodology