# K191225: EEG Electrode Template

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Aug 5, 2019 after 90 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 K780045 (1978). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043009: Brainet Kit, Jordan Neuroscience, Inc. (2005) Summary page 4.

## Indications for use
The EEG Electrode Template is intended for use as an accessory to support the placement of electroencephalograph (EEG) electrodes.

Source page: https://510kreport.com/device/K191225
Methodology: https://510kreport.com/methodology