# K251726: SignalNED System (Model RE)

- Pathway: 510(k) (Traditional)
- Applicant: Forest Devices, Inc.
- Decided: Sep 3, 2025 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: 4 generations back to K801604 (1980). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242306: SignalNED System (Model RE), Forest Devices, Inc. (2024) Summary page 5.
- K171414: qEEG-Pro, Brainmaster Technologies, Inc. (2018) Summary page 5.

## Indications for use
The SignalNED Device is intended to record and store EEG signals for the statistical evaluation of the human electroencephalogram (EEG) and display Quantitative EEG (qEEG) measures intended to help the user analyze the EEG. These measures include relative band power (e.g., alpha, beta, delta, theta) and band power asymmetry (displayed as a z-score compared to a normative database). The SignalNED does not provide any diagnostic conclusion about the patient’s condition. The device is intended to be used on adults by qualified medical and clinical professionals.

Source page: https://510kreport.com/device/K251726
Methodology: https://510kreport.com/methodology