# K162681: Enobio Wireless EEG

- Pathway: 510(k) (Traditional)
- Applicant: Neuroelectrics Barcelona S.L.U.
- Decided: Jun 2, 2017 after 249 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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 K001564 (2000). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103140: Nicolet Wireless Eeg, Carefusion 209, Inc. (2011) Summary page 5.

## Most influential descendants
- K261604: Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (2026), 0 descendants of its own

## Indications for use
ENOBIO is an EEG portable monitoring device of 8, 20, 32 channels intended for the use in clinical patient monitoring for use in hospitals and other medical environments. The Enobio is intended to acquire, store, transmit and display electrophysiological signals in wireless mode as an aid in diagnostics. The system digitizes analogue EEG signals collected by a cap with electrodes, amplifies them, and uses WiFi connectivity to transmit the EEG data to a dedicated host computer with the software. This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.

Source page: https://510kreport.com/device/K162681
Methodology: https://510kreport.com/methodology