# K131994: Somnolyzer 24X7

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Oct 17, 2013 after 111 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: 4 generations back to K873535 (1987). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083620: Somnolyzer 24X7, The Siesta Group North America (2009) Summary page 1.

## Most influential descendants
- K142988: Sleepware G3 (2015), 4 descendants of its own
- K202142: Sleepware G3 (2020), 2 descendants of its own
- K241960: DeepRESP (2025), 1 descendant of its own
- K250851: Hypnos (369054-200) (2025), 0 descendants of its own
- K252330: DeepRESP (2025), 0 descendants of its own

## Indications for use
Somnolyzer 247 is a 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/K131994
Methodology: https://510kreport.com/methodology