# K072201: Compumedics Somte PSG Recording System

- Pathway: 510(k) (Traditional)
- Applicant: Compumedics Limited
- Decided: Apr 14, 2008 after 250 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). 6 ancestors in all.
48 later devices descend from it; 3 cite it directly.
0 of 55 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 1.
- K021176: Compumedics Somte System, Compumedics Limited (2003) Summary page 1.

## Most influential descendants
- K111194: Apnea Risk Evaluation System (Ares) (2011), 40 descendants of its own
- K112514: Apnea Risk Evaluation System (Ares) (2012), 38 descendants of its own
- K120447: X4 (2012), 18 descendants of its own
- K130013: X4 System (2013), 17 descendants of its own
- K120450: Sleep Profiler (2012), 16 descendants of its own

## Indications for use
The Somt6 PSG is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders. The Somt6 PSG is designed for ambulatory and mobile operation and can be used in either the patient's home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible. The SomtM PSG is only to be used under the direction of a physician.

Source page: https://510kreport.com/device/K072201
Methodology: https://510kreport.com/methodology