# K200162: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

- Pathway: 510(k) (Abbreviated)
- Applicant: Wuhan Greentek Pty, Ltd.
- Decided: Apr 21, 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: 4 generations back to K780045 (1978). 5 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112319: Electro-Cap System, Electro-Cap Intl., Inc. (2012) Summary page 4.

## Most influential descendants
- K210805: Ceribell Instant EEG Headband (2021), 5 descendants of its own
- K232052: Ceribell Instant EEG Headband (2023), 3 descendants of its own
- K223086: Ceribell Instant EEG Headcap (2023), 3 descendants of its own
- K254033: Ceribell Instant EEG Headset (2026), 1 descendant of its own
- K260363: Ceribell Brain Monitor Headband (2026), 0 descendants of its own

## Indications for use
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.

Source page: https://510kreport.com/device/K200162
Methodology: https://510kreport.com/methodology