# K130238: Nihon Kohden AE-918P Neuro Unit

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corp.
- Decided: Mar 4, 2015 after 762 days
- Product code: OMA (Amplitude-Integrated 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: 9 generations back to K875179 (1988). 79 ancestors in all.
No later device cites it as a predicate yet.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080546: Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A, Nihon Kohden America, Inc. (2008) Summary page 4.
- K051178: Mee-1000A Neuromaster, Nihon Kohden America, Inc. (2005) Summary page 5.
- K963644: A-1000 Eeg Monitor and a-1050 Eeg Monitor, Aspect Medical Systems, Inc. (1996) Summary page 5.
- K021185: Nervus Monitor, Taugagreining HF (2002) Summary page 5.
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P, Nihon Kohden America, Inc. (2012) Summary page 5.
- K131789: Cerebralogik- Aeeg, Mennen Medical, Ltd. (2013). Cleared while this submission was under review Summary page 5.

## Indications for use
The AE-918P EEG Neuro Unit is an 8 channel EEG measuring unit that connects to a Nihon Kohden patient monitor and is intended to monitor brain function. The unit amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor. The AE-918P EEG Neuro Unit includes the calculation of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include quantitative EEG functions such as SEF, MDF, PPF, TP, CSA, DSA, %Delta, %Theta, %Alpha, %Beta, %Gamma, Abs Delta, Abs Theta, Abs Alpha, Abs Beta, and Abs Gamma. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveform. The aEEG functionality included in the AE-918P EEG Neuro Unit is intended to monitor the state of the brain. The device is intended for use by medical personnel in any location within a medical facility, physician’s office, laboratory, clinic or nursing home under direct supervision of a medical professional.

Source page: https://510kreport.com/device/K130238
Methodology: https://510kreport.com/methodology