# K021176: Compumedics Somte System

- Pathway: 510(k) (Traditional)
- Applicant: Compumedics Limited
- Decided: Jan 21, 2003 after 284 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 K000068 (2000). 2 ancestors in all.
95 later devices descend from it; 4 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000068: Compumedics E-Series Eeg System, Compumedics Neuro Science Pty, Ltd. (2000) Summary page 1.
- K002544: Medilog Excel 2 - Holter Management System, Oxford Instruments (2000) Summary page 1.

## Most influential descendants
- K072201: Compumedics Somte PSG Recording System (2008), 48 descendants of its own
- K073682: Embletta Gold (2008), 41 descendants of its own
- K111194: Apnea Risk Evaluation System (Ares) (2011), 40 descendants of its own
- K112514: Apnea Risk Evaluation System (Ares) (2012), 38 descendants of its own
- K122516: Embletta MPR (2013), 27 descendants of its own

## Indications for use
The SomtC System is a multi-functional ambulatory recording device intended to be used to collect and store signals related to sleep disorders, including respiratory signals, ECG signals and limb movement signals, to aid in the diagnosis of respiratory andor cardiac related sleep disorders. The SomtC System is not intended for use as life support equipment such as vital signs monitoring in intensive care units. The SomtC System is only to be used under the direction and supervision of a physician, technologist or clinician. It will not prevent or restore the interruption or loss of any physiological system.

Source page: https://510kreport.com/device/K021176
Methodology: https://510kreport.com/methodology