510(k) · Cleared
ClearedMPR2 logO DATALOGGER
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raumedic AG · GWM Device, Monitoring, Intracranial Pressure
Cleared on Jul 6, 2017 as substantially equivalent to K130529 (Raumedic AG, 2013) and 1 other predicate after a 31-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Jul 6, 2017
- Review
- 31 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914479 (1994). 20 ancestors in all, the oldest K813459 (1982). No later device cites it as a predicate yet.
- Root · 6 generations backK914479 Microsensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. · 1994 · Recalled
- 5 generations backK062584 Pressio Icp Monitoring SystemSophysa SA · 2007 · Recalled
- 4 generations backK103206 Raumedic- Icp-Monitoring SystemRaumedic AG · 2011
- 3 generations backK112017 Raumedic Icp Monitoring SystemRaumedic AG · 2011
- 2 generations backK120252 Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012
- 1 generation backK130529 Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013
- This deviceK171666 MPR2 logO DATALOGGERRaumedic AG · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914479 | Microsensor Intracranial Pressure Transducer | Codman & Shurtleff, Inc. | 1994 | 3 |
| −5 | K062584 | Pressio Icp Monitoring System | Sophysa SA | 2007 | 2 |
| −4 | K103206 | Raumedic- Icp-Monitoring System | Raumedic AG | 2011 | — |
| −3 | K112017 | Raumedic Icp Monitoring System | Raumedic AG | 2011 | — |
| −2 | K120252 | Raumedic-Icp-Temp-Monitoring-System | Raumedic AG | 2012 | — |
| −1 | K130529 | Raumedic-Pto-Monitoring-System | Raumedic AG | 2013 | — |
| 0 (this device) | K171666 | MPR2 logO DATALOGGER | Raumedic AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWM device
- #1 K252241 Pressio 3 Multi-parameter Neuromonitoring Systemscore 12.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130529 | Raumedic-Pto-Monitoring-SystemSummary page 5…ly equivalent to those of the legally marketed predicate devices, the EASY logO as part of the RAUMEDIC® -PTO-Monitoring-System which was cleared to market under 510 (k) K130529 on 25th of October 2013 and the INTEGRA CAMINO ICP MONITOR which was cleared to market under 510 (k) K121573 on 10th of September… | 2013 |
| * | K121573 | Integra Camino Icp MonitorSummary page 5…-Monitoring-System which was cleared to market under 510 (k) K130529 on 25th of October 2013 and the INTEGRA CAMINO ICP MONITOR which was cleared to market under 510 (k) K121573 on 10th of September 2012. Fur further information see device comparison tables attached. Based on performance testing and the… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 7 of the 20 ancestors have a recall of any class.
- 2 other devices also cite its predicate K130529.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GWM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWM
30in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWM
3in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · GWM
441in 2025
MAUDE reports naming product code GWM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 126 |
| 2008 | 2 | — | 1 | 105 |
| 2009 | 1 | — | 0 | 117 |
| 2010 | 2 | — | 9 | 104 |
| 2011 | 3 | 123 | 6 | 184 |
| 2012 | 4 | 100 | 1 | 151 |
| 2013 | 2 | — | 12 | 120 |
| 2014 | 2 | — | 2 | 360 |
| 2015 | 0 | — | 0 | 486 |
| 2016 | 3 | 192 | 0 | 419 |
| 2017 | 3 | 37 | 0 | 445 |
| 2018 | 1 | — | 0 | 302 |
| 2019 | 2 | — | 1 | 260 |
| 2020 | 3 | 30 | 0 | 268 |
| 2021 | 2 | — | 0 | 211 |
| 2022 | 0 | — | 0 | 424 |
| 2023 | 0 | — | 1 (1) | 744 |
| 2024 | 2 | — | 4 (2) | 641 |
| 2025 | 1 | — | 3 | 441 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171666: MPR2 logO DATALOGGER.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171666
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026