# K140861: Somnotouch Resp

- Pathway: 510(k) (Traditional)
- Applicant: Somnomedics GmbH
- Decided: Jan 30, 2015 after 302 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: 3 generations back to K000396 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060708: Somnoscreen, Somnomedics GmbH & Co. KG (2007) Summary page 4.

## Indications for use
The SOMNOtouch RESP is a portable physiological signal recorder. It is indicated for use in the recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of assisting in the diagnosis of sleep disorders and sleep related respiratory disorders of adult patients. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient’s home. This device is NOT designed to be used in life support situations.

Source page: https://510kreport.com/device/K140861
Methodology: https://510kreport.com/methodology