# K231366: Neuronaute Plus

- Pathway: 510(k) (Traditional)
- Applicant: Bioserenity Sas
- Decided: Nov 9, 2023 after 182 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: 4 generations back to K830295 (1983). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202334: Neuronaute, Bioserenity Sas (2020) Summary page 6.

## Most influential descendants
- K261101: Ceribell Monitor (2026), 0 descendants of its own

## Indications for use
The Neuronaute Plus is a system intended to acquire, store, archive, and periodically transmit physiological signals from the brain using a full montage array to enable review at a physician’s office, hospital, or other remote locations. It allows remote access by users via the BioSerenity Cloud. The Neuronaute Plus and its associated software are intended to assist in the diagnosis of neurological disorders. The Neuronaute Plus and its components do not provide any diagnostic conclusions or automated alerts of an adverse clinical event about a patient's clinical condition. The Neuronaute Plus is intended to be used by trained healthcare professionals, technicians or patients above 15 years old. In case of a patient below 15 years old, Neuronaute Plus is intended to be used by a care giver. Adequate training is recommended for proper use of the device. Neuronaute IceCap 2 electrodes are able to be used on patients weighing at least 10 kg and having a head circumference above 43 cm. Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis. The BioSerenity Cloud allows the display of signals in order to help aid in the diagnosis of physiological disorders through the data collected by recording. The BioSerenity Cloud should allow the analysis and filtering of data in order to aid doctors in diagnosing neurological disorders.

Source page: https://510kreport.com/device/K231366
Methodology: https://510kreport.com/methodology