# K112102: Michele Sleep Scoring Systems

- Pathway: 510(k) (Traditional)
- Applicant: Younes Sleep Technologies
- Decided: Dec 20, 2011 after 151 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 K962603 (1997). 15 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040595: ALICE 5, Respironics, Inc. (2004) Summary page 1.
- K022506: Morpheus 1, Automated Sleep Study Scoring & Data Management System, Widemed, Ltd. (2003) Summary page 2.
- K083620: Somnolyzer 24X7, The Siesta Group North America (2009) Summary page 2.

## Most influential descendants
- 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
- K221179: SomnoMetry (2022), 3 descendants of its own

## Indications for use
The MICHELE Sleep Scoring System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarizing, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.

Source page: https://510kreport.com/device/K112102
Methodology: https://510kreport.com/methodology