# K162460: WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts

- Pathway: 510(k) (Traditional)
- Applicant: Wavi Co.
- Decided: Apr 28, 2017 after 238 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.
1 later device descends from it; 1 cites it directly.
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 4.
- K780045: Electrode Cap, Electro-Cap Intl., Inc. (1978) Summary page 5.

## Most influential descendants
- K202913: NeuroCap (Model DEC22) (2021), 0 descendants of its own

## Indications for use
The WAVi Headset 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/K162460
Methodology: https://510kreport.com/methodology