# K223676: SomniCheck

- Pathway: 510(k) (Traditional)
- Applicant: Brainmatterz, LLC
- Decided: Jun 1, 2023 after 175 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- 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 K003154 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040113: Sandman SD20 Amplifier, Eb Neuro S.P.A. (2004) Summary page 4.
- K220631: NomadAir PMU810, Neurotronics, Inc. (2022) Summary page 4.

## Indications for use
SomniCheck is a prescription-use, single use physiological data recorder intended to amplify, digitize, and record data from multiple physiological channels for subsequent transfer to polysomnography systems. The device measures the following signals: • EEG (4-channel), • PPG (by Maxim), • Temperature, • 3-axis accelerometer, • Gyroscope (position), and • Audio/ sound for snoring. It is intended for use on adult patients (18 and older) and can be used in a hospital, clinic, or home.

Source page: https://510kreport.com/device/K223676
Methodology: https://510kreport.com/methodology