# K240646: DreamClear

- Pathway: 510(k) (Traditional)
- Applicant: Somnomed Technologies Inc., Doing Business AS Remware
- Decided: Sep 4, 2024 after 181 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: 1 generation back to K092699 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092699: Nomad Sleep System Recorder, Model PMU800, Neurotronics, Inc. (2010) Summary page 5.

## Indications for use
DreamClear is intended for use on both adults and children to collect, amplify, and transmit physiological signals, including electroencephalogram (EEG), electrooculography (EOG), limb movement, respiration effort, air pressure, and peripheral oxygen saturation (SpO2). DreamClear is intended for use on the order of a physician and is non-sterile. While primarily intended for use with dedicated polysomnography software to aid in the diagnosis of sleep disorders, DreamClear may be used to amplify physiological signals for any medical diagnostic procedure that does not involve: - use alone as an apnea monitor or as a critical component in an apnea monitoring system; or - use alone as a life support device or as a critical component of a life support system.

Source page: https://510kreport.com/device/K240646
Methodology: https://510kreport.com/methodology