# K251550: NX01 (NX01)

- Pathway: 510(k) (Traditional)
- Applicant: Naox Technologies Sas
- Decided: Nov 25, 2025 after 188 days
- Product code: OMC (Reduced- 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: 10 generations back to K963644 (1996). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192549: Byteflies Kit, Byteflies NV (2020) Summary page 11.

## Indications for use
NX01 is intended for use in healthcare or home settings to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes in the ears of patients. It acquires, records and transmits one channel of electroencephalogram (EEG) data. The medical use of data acquired by NX01 is to be performed under the direction and interpretation of a licensed medical professional. NX01 does not provide any diagnostic conclusions about the patient's condition. The NX01 is intended for use with adult and pediatric patients (6+).

Source page: https://510kreport.com/device/K251550
Methodology: https://510kreport.com/methodology