# Somnomedics GmbH

- Location (FDA's records): Randersacker, DE
- FDA decisions: 8 (2007–2024): 8 510(k) clearances
- Names in FDA's records: Somnomedics GmbH (7); Somnomedics GmbH & Co. KG (1)
- Product codes: MNR (4), OLV (2), DSH (1), GYB (1)
- Predicates its devices cite: 12 (6 its own); citations of its devices by later devices: 9 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vasomedical, Inc.: 1 (https://510kreport.com/company/vasomedical)
- Spes Medica Srl: 1 (https://510kreport.com/company/spes-medica)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)
- Individual Monitoring Systems, Inc.: 1 (https://510kreport.com/company/individual-monitoring-systems)
- Erich Jaeger, Inc.: 1 (https://510kreport.com/company/erich-jaeger)
- Compumedics Limited: 1 (https://510kreport.com/company/compumedics)

## Firms that cite its devices most
- Widemed, Ltd.: 1 (https://510kreport.com/company/widemed)
- Biancamed Limited: 1 (https://510kreport.com/company/biancamed)
- Nox Medical Ehf: 1 (https://510kreport.com/company/nox-medical)

## Its most-cited devices
- K060708: Somnoscreen (2007), cited by 6
- K201054: SOMNOscreen plus (2020), cited by 2
- K071556: Somnoscreen EEG10-20 (2007), cited by 1

## Recent decisions
- K240700: HomeSleepTest (HST, HST REM+) (Dec 8, 2024)
- K231104: ABPMpro (Nov 27, 2023)
- K212325: EEG-acp (Jun 15, 2022)
- K201054: SOMNOscreen plus (Aug 12, 2020)
- K140861: Somnotouch Resp (Jan 30, 2015)
- K081485: Somnowatch (Sep 18, 2008)
- K071556: Somnoscreen EEG10-20 (Jul 18, 2007)
- K060708: Somnoscreen (Jan 24, 2007)

Source page: https://510kreport.com/company/somnomedics