# K251366: EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: Oct 9, 2025 after 161 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- 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 K003154 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 6.
- K101691: Lifelines Photic Stimulator, Lifelines, Ltd. (2010) Summary page 9.

## Indications for use
EEG-1260A Neurfax System The EEG-1260A series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in sleep disorders, epilepsies and other related disorders as an aid in diagnosis. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic, or nursing home or outside of a medical facility under direct supervision of a medical professional. JE-940A EEG Amplifier Unit The EEG amplifier unit is intended to acquire and record the EEG and other biological signals (ECG, EMG, respiration, EOG, snoring, body position, SpO2, pulse waveform) of a patient, and transmit the measurement data to the electroencephalograph. The transmitted measurement data is displayed on the electroencephalograph screen and provides information to evaluate the functional state of the brain, brain-related diseases and disorders, and sleep disorders. The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel. The device is available for use on any patient as determined by qualified medical personnel. LS-940A Photic Light The photic stimulator is a light source for photic stimulation to confirm the responsiveness of EEG to photic stimulation during EEG tests and to test visual evoked potentials. The device is intended for use by qualified medical personnel within a medical facility, or by staff in an equivalent facility under the direct supervision of qualified medical personnel. The device is available for use on any patient as determined by qualified medical personnel.

Source page: https://510kreport.com/device/K251366
Methodology: https://510kreport.com/methodology