# K071118: Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and Conductive Plastic Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ives Eeg Solutions, Inc.
- Decided: Sep 7, 2007 after 140 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 K022197 (2002). 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)
- K032278: Ambu Neuroline Single Patient Eeg/EP Cup Electrode, Ambu, Inc. (2004) Summary page 1.
- K022197: Surface Electrode for Electroencephalography, The Electrode Store, Inc. (2002) Summary page 1.
- (no number) Surface EEG Electrode: named in the summary without a submission number

## Most influential descendants
- 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 cutaneous, surface cup electrode system is intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording.

Source page: https://510kreport.com/device/K071118
Methodology: https://510kreport.com/methodology