# K112017: Raumedic Icp Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Raumedic AG
- Decided: Oct 11, 2011 after 89 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- 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 K914479 (1994). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103206: Raumedic- Icp-Monitoring System, Raumedic AG (2011) Summary page 2.
- K062584: Pressio Icp Monitoring System, Sophysa SA (2007) Summary page 3.

## Most influential descendants
- K120252: Raumedic-Icp-Temp-Monitoring-System (2012), 5 descendants of its own
- K130529: Raumedic-Pto-Monitoring-System (2013), 4 descendants of its own
- K162108: Pressio 2 ICP Monitoring System (2017), 1 descendant of its own
- K252241: Pressio 3 Multi-parameter Neuromonitoring System (2026), 0 descendants of its own
- 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 (2025), 0 descendants of its own

## Indications for use
The RAUMEDIC -ICP-Monitoring-System ventricular is Indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. Use of the ventricular intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC® catheters are MR Unsafe.

Source page: https://510kreport.com/device/K112017
Methodology: https://510kreport.com/methodology