# K083620: Somnolyzer 24X7

- Pathway: 510(k) (Traditional)
- Applicant: The Siesta Group North America
- Decided: Mar 6, 2009 after 88 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: 3 generations back to K873535 (1987). 4 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022506: Morpheus 1, Automated Sleep Study Scoring & Data Management System, Widemed, Ltd. (2003) Summary page 1.

## Most influential descendants
- 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
- K162627: EnsoSleep (2017), 9 descendants of its own

## Indications for use
somnolyzer 24X7 isa computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders. Somnolyzer 24X7 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/K083620
Methodology: https://510kreport.com/methodology