# Raumedic AG

- Location (FDA's records): Helmbrechts, DE
- FDA decisions: 6 (2011–2025): 6 510(k) clearances
- Product codes: GWM (6)
- Predicates its devices cite: 17 (10 its own); citations of its devices by later devices: 12 (10 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
- Sophysa SA: 2 (https://510kreport.com/company/sophysa)
- Intrgra Lifesciences Corporation: 1 (https://510kreport.com/company/intrgra-lifesciences)
- Codman & Shurtleff, Inc.: 1 (https://510kreport.com/company/codman-shurtleff)
- Diametrics Medical, Inc.: 1 (https://510kreport.com/company/diametrics-medical)
- Integra Neurosciences: 1 (https://510kreport.com/company/integra-neurosciences)
- Camino Neurocare, Inc.: 1 (https://510kreport.com/company/camino-neurocare)

## Firms that cite its devices most
- Sophysa SA: 2 (https://510kreport.com/company/sophysa)

## Its most-cited devices
- K103206: Raumedic- Icp-Monitoring System (2011), cited by 4
- K130529: Raumedic-Pto-Monitoring-System (2013), cited by 3
- K120252: Raumedic-Icp-Temp-Monitoring-System (2012), cited by 3
- K112017: Raumedic Icp Monitoring System (2011), cited by 2

## Recent decisions
- K250285: Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003); Neurovent-Ifd-S (091678-003); Neurovent-P-Temp (094268-003); Neurovent-Temp (094278-003); Neurovent-Temp-Ifd-R (095327-003); Neurovent-Temp-Ifd-S (094288-003); Neurovent-Pto (095008-003); Neurovent-Pto 2L (095108-003); Neurovent-PX (091580-003); Bolt-Drill Kit CH5 (091888-003); Bolt-Drill Kit CH9 (091898-003); Bolt-Drill Kit Pto (092380-003); Bolt-Drill Kit VP 16 (092969-003); Bolt Kit CH5 (091868-003); Bol (Aug 29, 2025)
- K171666: MPR2 logO DATALOGGER (Jul 6, 2017)
- K130529: Raumedic-Pto-Monitoring-System (Oct 25, 2013)
- K120252: Raumedic-Icp-Temp-Monitoring-System (Apr 11, 2012)
- K112017: Raumedic Icp Monitoring System (Oct 11, 2011)
- K103206: Raumedic- Icp-Monitoring System (Mar 4, 2011)

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