# K081485: Somnowatch

- Pathway: 510(k) (Traditional)
- Applicant: Somnomedics GmbH
- Decided: Sep 18, 2008 after 113 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 K854030 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992410: Actitrac, Individual Monitoring Systems, Inc. (1999) Summary page 1.
- K060708: Somnoscreen, Somnomedics GmbH & Co. KG (2007)

## Indications for use
The SOMNOwatch is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having movement-correlated sleep disturbances.

Source page: https://510kreport.com/device/K081485
Methodology: https://510kreport.com/methodology