# K060708: Somnoscreen

- Pathway: 510(k) (Traditional)
- Applicant: Somnomedics GmbH & Co. KG
- Decided: Jan 24, 2007 after 314 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 K000396 (2000). 3 ancestors in all.
11 later devices descend from it; 6 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021138: Sleepscreen/Apnoescreen Cardio, Erich Jaeger GmbH (2003) Summary page 1.
- K003175: Compumedics Siesta System, Compumedics Limited (2000) Summary page 1.

## Most influential descendants
- K071556: Somnoscreen EEG10-20 (2007), 5 descendants of its own
- K201054: SOMNOscreen plus (2020), 4 descendants of its own
- K241288: Noxturnal Web (2024), 2 descendants of its own
- K103631: Sleepminder Breathing Frequency Indicator (2011), 1 descendant of its own
- K261747: Report Studio (2026), 0 descendants of its own

## Indications for use
The SOMNOscreen is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleep-related breathing disorders.

Source page: https://510kreport.com/device/K060708
Methodology: https://510kreport.com/methodology