# K211315: Comby EEG Caps

- Pathway: 510(k) (Traditional)
- Applicant: Pamel D.O.O
- Decided: Nov 9, 2021 after 193 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: 5 generations back to K780045 (1978). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 5.
- K200162: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP), Wuhan Greentek Pty, Ltd. (2020) Summary page 5.
- K110223: Waveguard (TM) Eeg Cap, Eemagine Medical Imaging Solutions GmbH (2011) Summary page 5.

## Indications for use
The Comby EEG Cap is intended for use in routine clinical settings where rapid placement of large number of EEG electrodes is desired.

Source page: https://510kreport.com/device/K211315
Methodology: https://510kreport.com/methodology