# K242930: Natus BrainWatch System

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Decided: Nov 19, 2024 after 56 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: 6 generations back to K780045 (1978). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170363: Ceribell Pocket EEG Device, Ceribell, Inc. (2017) Summary page 6.
- K210805: Ceribell Instant EEG Headband, Ceribell, Inc. (2021) Summary page 6.

## Indications for use
The Natus BrainWatch System including the Natus BrainWatch Headband, is intended to record and store EEG signals and present these signals visually to assist trained medical staff in making neurological diagnoses in patients aged 2 years and older. The device does not provide any diagnostic conclusions about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Natus BrainWatch System is intended for use within a professional healthcare facility or clinical research environment. The Natus BrainWatch Headband is intended for single-patient use.

Source page: https://510kreport.com/device/K242930
Methodology: https://510kreport.com/methodology