# K172703: Disposable Snap Electrode

- Pathway: 510(k) (Abbreviated)
- Applicant: Embla Systems
- Decided: Nov 13, 2017 after 67 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 K941799 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142159: Disposable Pre-Gelled Surface Electrode, Rochester Electro Medical, Inc. (2015) Summary page 4.
- K021537: Multipurpose Neuroplus Electrode, Model A10005, Vermont Medical, Inc. (2003) Summary page 4.

## Indications for use
The Disposable Snap Electrodes are intended to be used with compatible 1.5mm touchproof button snap cables for transferring surface biopotential signals to use during sleep studies, EEG, EMG, and recording evoked potential signals from a cutaneous location. For use on Adults.

Source page: https://510kreport.com/device/K172703
Methodology: https://510kreport.com/methodology