# K073532: Disposable Adhesive Surface Electrodes, Disc Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Technomed Europe
- Decided: May 1, 2008 after 136 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: 1 generation back to K971914 (1998). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000870: KM-10 Tens Electrode, Katecho, Inc. (2000) Summary page 1.
- K971914: Teca NCS Electrode System 2000, Medelec, Inc. D.B.A. Teca Corp. (1998) Summary page 1.

## Most influential descendants
- K211839: Electrode Market Disposable Surface Electrodes (2021), 0 descendants of its own
- K180247: DAEHAN Adhesive Surface Electrodes (2018), 0 descendants of its own

## Indications for use
The Disposable 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/K073532
Methodology: https://510kreport.com/methodology