# K261604: Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)

- Pathway: 510(k) (Special)
- Applicant: Neuroelectrics Barcelona S.L.U.
- Decided: Jun 13, 2026 after 30 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: 6 generations back to K001564 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162681: Enobio Wireless EEG, Neuroelectrics Barcelona S.L.U. (2017) Summary page 5.

## Indications for use
Enobio Dx is a wireless, battery-operated, and portable electrophysiology sensor system for the recording of electroencephalograms (EEG). Enobio Dx is available in three different models capable of providing either 8, 20, or 32 channels respectively. Enobio are portable EEG monitoring devices of 8, 20, and 32 channels intended for 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 as an aid in diagnostics. The system digitizes analogue EEG signals collected by a cap with electrodes 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/K261604
Methodology: https://510kreport.com/methodology