# K201054: SOMNOscreen plus

- Pathway: 510(k) (Traditional)
- Applicant: Somnomedics GmbH
- Decided: Aug 12, 2020 after 113 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962603 (1997). 15 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040595: ALICE 5, Respironics, Inc. (2004) Summary page 5.
- K071556: Somnoscreen EEG10-20, Somnomedics GmbH (2007) Summary page 5.
- K060708: Somnoscreen, Somnomedics GmbH & Co. KG (2007) Summary page 5.

## Most influential descendants
- K241288: Noxturnal Web (2024), 2 descendants of its own
- K261747: Report Studio (2026), 0 descendants of its own
- K260585: Noxturnal Web (2026), 0 descendants of its own
- K240700: HomeSleepTest (HST, HST REM+) (2024), 0 descendants of its own

## Indications for use
The SOMNOscreen® plus is a non-life-supporting portable physiological signal recording device intended to be used for testing adults and children (age 2 to 12 years)/adolescents (age 12 and above) suspected of having sleep-related breathing disorders.

Source page: https://510kreport.com/device/K201054
Methodology: https://510kreport.com/methodology