# K022506: Morpheus 1, Automated Sleep Study Scoring & Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Widemed, Ltd.
- Decided: May 15, 2003 after 289 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- 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 K873535 (1987). 3 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955841: Sleep System for Clinics & Research, Compumedics Ptd, Ltd. (1997) Summary page 2.

## Most influential descendants
- K083620: Somnolyzer 24X7 (2009), 25 descendants of its own
- K112102: Michele Sleep Scoring Systems (2011), 18 descendants of its own
- K120450: Sleep Profiler (2012), 16 descendants of its own
- K130007: Sleep Profiler (2013), 14 descendants of its own
- K153412: Sleep Profiler (2016), 13 descendants of its own

## Indications for use
The MorpheusTM1 Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders. The MorpheusTM1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. This device is to be used under the supervision of a physician.

Source page: https://510kreport.com/device/K022506
Methodology: https://510kreport.com/methodology