# K192469: Nox Sleep System

- Pathway: 510(k) (Traditional)
- Applicant: Nox Medical
- Decided: Nov 13, 2019 after 65 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: 3 generations back to K873535 (1987). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072201: Compumedics Somte PSG Recording System, Compumedics Limited (2008) Summary page 4.

## Most influential descendants
- K241960: DeepRESP (2025), 1 descendant of its own
- K223539: Dreem 3S (2023), 1 descendant of its own
- K252330: DeepRESP (2025), 0 descendants of its own
- K242094: Dreem 3S (2024), 0 descendants of its own

## Indications for use
The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre-defined reports based on subject´s data. The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home.

Source page: https://510kreport.com/device/K192469
Methodology: https://510kreport.com/methodology