# K200540: BRAINSTREAM Disposable Deep Cup EEG Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Jun 1, 2020 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: 1 generation back to K032278 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
The single patient EEG Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals, for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.

Source page: https://510kreport.com/device/K200540
Methodology: https://510kreport.com/methodology