# K183529: AE-120A EEG Head Set

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: Mar 19, 2019 after 90 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: 2 generations back to K830295 (1983). 4 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 14 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 5.
- K171459: Ceribell Instant EEG Headband, Ceribell, Inc. (2017) Summary page 6.

## Most influential descendants
- K202334: Neuronaute (2020), 4 descendants of its own
- K203827: REMI (2021), 3 descendants of its own
- K231366: Neuronaute Plus (2023), 1 descendant of its own
- K230933: REMI Remote EEG Monitoring System (2023), 1 descendant of its own
- K223644: Neuronaute with IceCap 2 & IceCap 2 Small (2023), 1 descendant of its own

## Indications for use
The AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional using the previously cleared and validated Nihon Kohden electroencephalograph systems (EEG-1200A series and EEG-9100) to assist in the diagnosis of neurological disorders. The AE-120A EEG Head Set and its associated EEG Software do not provide any diagnostic conclusion or automated alerts of an adverse clinical event about a patient's condition. The device is intended for use by trained medical professionals in a medical facility such as a physician’s office, laboratory, or clinic. The device is intended for use on adults (ages 18 and above).

Source page: https://510kreport.com/device/K183529
Methodology: https://510kreport.com/methodology