# K120252: Raumedic-Icp-Temp-Monitoring-System

- Pathway: 510(k) (Traditional)
- Applicant: Raumedic AG
- Decided: Apr 11, 2012 after 75 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: 4 generations back to K914479 (1994). 13 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962928: Combined Intracranial Pressure-Temperature Sensing System (Icp/), Camino Neurocare, Inc. (1996) Summary page 3.
- K103206: Raumedic- Icp-Monitoring System, Raumedic AG (2011) Summary page 2.
- K112017: Raumedic Icp Monitoring System, Raumedic AG (2011) Summary page 3.

## Most influential descendants
- 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
- K171666: MPR2 logO DATALOGGER (2017), 0 descendants of its own

## Indications for use
The RAUMEDIC® -ICP-TEMP-Monitoring-System is indicated for use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the parenchyma and in the ventricle and cerebrospinal fluid drainage applications. Use of the parenchymal and 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/K120252
Methodology: https://510kreport.com/methodology