# K022197: Surface Electrode for Electroencephalography

- Pathway: 510(k) (Traditional)
- Applicant: The Electrode Store, Inc.
- Decided: Aug 13, 2002 after 39 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071118: Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and Conductive Plastic Electrode (2007), 2 descendants of its own
- K171102: Ives MR Conditional Cup Electrode (2017), 0 descendants of its own
- K163547: MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 (2017), 0 descendants of its own

## Indications for use
The Electrode StoreTM Surface Electrodes for Electroencephalography are intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.

Source page: https://510kreport.com/device/K022197
Methodology: https://510kreport.com/methodology