# K223539: Dreem 3S

- Pathway: 510(k) (Traditional)
- Applicant: Beacon Biosignals, Inc.
- Decided: Aug 18, 2023 after 268 days
- Product code: OLZ (Automatic Event Detection Software For Polysomnograph With 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 K873535 (1987). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192469: Nox Sleep System, Nox Medical (2019) Summary page 4.

## Most influential descendants
- K242094: Dreem 3S (2024), 0 descendants of its own

## Indications for use
The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep and awake in the home or healthcare environment. The Dreem 3S can also output a hypnogram of sleep scoring by 30-second epoch and summary of sleep metrics derived from this hypnogram. The Dreem 3S is used for the assessment of sleep on adult individuals (22 to 65 years old). The Dreem 3S allows for the generation of user/predefined reports based on the subject’s data.

Source page: https://510kreport.com/device/K223539
Methodology: https://510kreport.com/methodology