# K103206: Raumedic- Icp-Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Raumedic AG
- Decided: Mar 4, 2011 after 123 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: 2 generations back to K914479 (1994). 5 ancestors in all.
7 later devices descend from it; 4 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)
- K062584: Pressio Icp Monitoring System, Sophysa SA (2007) Summary page 3.

## Most influential descendants
- K112017: Raumedic Icp Monitoring System (2011), 6 descendants of its own
- 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

## Indications for use
The RAUMEDICO -ICP-Manitoring-Systemn is indicated for use in parenchymal pressure monitoring. Use of the parenchymal intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC@ precision pressure catheters are MR Unsafe.

Source page: https://510kreport.com/device/K103206
Methodology: https://510kreport.com/methodology