# K180247: DAEHAN Adhesive Surface Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Daehan Medical Systems Co., Ltd.
- Decided: Nov 1, 2018 after 276 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 DAEHAN Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the, patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.

Source page: https://510kreport.com/device/K180247
Methodology: https://510kreport.com/methodology