# K250851: Hypnos (369054-200)

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Industries, Inc.
- Decided: Dec 14, 2025 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: 6 generations back to K873535 (1987). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142988: Sleepware G3, Respironics, Inc. (2015) Summary page 5.

## Indications for use
Cadwell Hypnos is a software application used for Polysomnography (PSG) and other clinical sleep studies. It is intended for use by research and clinical sleep professionals. It measures, records, displays, organizes, analyzes, summarizes, and retrieves physiological signals during sleep and wake used to assist in the assessment of sleep and the diagnosis of various sleep disorders including sleep related breathing disorders. The software can be used for analysis (computer-assisted as well as manual scoring of events), display, retrieval, summarization, reporting and networking of data received from devices used to monitor sleep related parameters. Hypnos is indicated for use in all sleep disorders patient populations from neonate to adult, including infants, pediatrics and geriatric populations. Computer-assisted analysis features of the application are only intended for use on adults. Hypnos is only indicated for use by trained medical professionals for the purpose of assessing sleep disorders. Intended environments include hospitals, institutions, sleep centers, sleep clinics, and other sleep disorders testing environments. Hypnos is NOT intended to be used to perform automatic diagnosis.

Source page: https://510kreport.com/device/K250851
Methodology: https://510kreport.com/methodology