# K171666: MPR2 logO DATALOGGER

- Pathway: 510(k) (Traditional)
- Applicant: Raumedic AG
- Decided: Jul 6, 2017 after 31 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: 6 generations back to K914479 (1994). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130529: Raumedic-Pto-Monitoring-System, Raumedic AG (2013) Summary page 5.
- K121573: Integra Camino Icp Monitor, Intrgra Lifesciences Corporation (2012) Summary page 5.

## Indications for use
The RAUMEDIC® MPR2 is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure, temperature as well as to determine the partial oxygen pressure ptiO2 of the interstitial fluid.

Source page: https://510kreport.com/device/K171666
Methodology: https://510kreport.com/methodology