# K242306: SignalNED System (Model RE)

- Pathway: 510(k) (Traditional)
- Applicant: Forest Devices, Inc.
- Decided: Sep 4, 2024 after 30 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 K964280 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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.
- K143487: Lifelines iEEG, Kvikna Ehf (2015) Summary page 5.
- K171459: Ceribell Instant EEG Headband, Ceribell, Inc. (2017) Summary page 5.

## Most influential descendants
- K251726: SignalNED System (Model RE) (2025), 0 descendants of its own

## Indications for use
The SignalNED Device is intended to record and store EEG signals and display Quantitative EEG (qEEG) (relative band power, e.g., alpha, beta, delta, theta), which is intended to help the user analyze the EEG. 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. The SignalNED is intended to be used in a professional healthcare environment.

Source page: https://510kreport.com/device/K242306
Methodology: https://510kreport.com/methodology