# K955841: Sleep System for Clinics & Research

- Pathway: 510(k) (Traditional)
- Applicant: Compumedics Ptd, Ltd.
- Decided: Mar 11, 1997 after 445 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: 1 generation back to K873535 (1987). 2 ancestors in all.
63 later devices descend from it; 5 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873535: Nicolet Expert Sleep/Wake Analysis System, Nicolet Biomedical Instruments (1987) Summary page 3.
- K915856: Sensormedics 4000 Series Sleep System, Sensor Medics Corp. (1992) Summary page 3.

## Most influential descendants
- K072201: Compumedics Somte PSG Recording System (2008), 48 descendants of its own
- K111194: Apnea Risk Evaluation System (Ares) (2011), 40 descendants of its own
- K072014: Vitascore (2007), 40 descendants of its own
- K082968: Apneicare Connection Center/Internet Analysis (2009), 39 descendants of its own
- K112514: Apnea Risk Evaluation System (Ares) (2012), 38 descendants of its own

## Indications for use
The Compumedics Sleep Monitoring System is used as an aid in the diagnosis of sleep and respiratory related sleep disorders. The use of this sleep monitoring system is to be under the supervision of a physician, sleep technologist or clinician. The Compumedics Sleep Monitoring System is an information management tool to record, display, organise, summarise, redisplay (retrieve) and generate user-defined reports based on the subject’s data received from monitoring devices typically used to evaluate sleep and sleep related respiratory disorders. The users of the Compumedics Sleep Monitoring System are medical professionals who have received training in the areas of hospital procedures, physiological monitoring of human subjects, and sleep disorder investigation.

Source page: https://510kreport.com/device/K955841
Methodology: https://510kreport.com/methodology