# K110223: Waveguard (TM) Eeg Cap

- Pathway: 510(k) (Traditional)
- Applicant: Eemagine Medical Imaging Solutions GmbH
- Decided: Jun 29, 2011 after 155 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: 2 generations back to K780045 (1978). 3 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780045: Electrode Cap, Electro-Cap Intl., Inc. (1978) Summary page 1.
- K071446: Electrode Array Cap, Electrode Arrays (2008) Summary page 1.

## Most influential descendants
- K112319: Electro-Cap System (2012), 16 descendants of its own
- K200162: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) (2020), 9 descendants of its own
- 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

## Indications for use
This is an EEG electrode set intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.

Source page: https://510kreport.com/device/K110223
Methodology: https://510kreport.com/methodology