# K130529: Raumedic-Pto-Monitoring-System

- Pathway: 510(k) (Traditional)
- Applicant: Raumedic AG
- Decided: Oct 25, 2013 after 238 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: 5 generations back to K914479 (1994). 18 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980380: Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter Sensor, MPM7001S, and Satellite MS, Diametrics Medical, Ltd. (1999) Summary page 3.
- K002765: Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer Kits-IM,IM2,IM3,II1 Licoximc Tempe, Integra Neurosciences (2000) Summary page 9.
- K120252: Raumedic-Icp-Temp-Monitoring-System, Raumedic AG (2012) Summary page 4.
- K103206: Raumedic- Icp-Monitoring System, Raumedic AG (2011) Summary page 3.

## Most influential descendants
- 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® - PTO-Monitoring-System measures intracranial pressure, temperature and oxygen and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. RAUMEDIC® - PTO-Monitoring-System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia or ischemia is a concern. Use of the parenchymal intracranial pressure monitoring kit with bolt is indicated for children who are at least one year old.

Source page: https://510kreport.com/device/K130529
Methodology: https://510kreport.com/methodology