# K112319: Electro-Cap System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Cap Intl., Inc.
- Decided: Jan 27, 2012 after 169 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: 3 generations back to K780045 (1978). 4 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 21 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.
- K000865: Quik-Cap, Neuroscan (2000) Summary page 1.
- K110223: Waveguard (TM) Eeg Cap, Eemagine Medical Imaging Solutions GmbH (2011) Summary page 1.

## Most influential descendants
- 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
- K171669: g.Nautilus PRO (2017), 2 descendants of its own

## Indications for use
The Electro-Cap System is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.

Source page: https://510kreport.com/device/K112319
Methodology: https://510kreport.com/methodology