510(k) · Cleared
ClearedRaumedic-Icp-Temp-Monitoring-System
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 Apr 11, 2012 as substantially equivalent to K962928 (Camino Neurocare, Inc., 1996) and 2 other predicates after a 75-day review. Its family tree reaches back 4 generations to 1994. 5 later devices descend from it.
- Decided
- Apr 11, 2012
- Review
- 75 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K914479 (1994). 13 ancestors in all, the oldest K813459 (1982). 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK914479 Microsensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. · 1994 · Recalled
- 3 generations backK062584 Pressio Icp Monitoring SystemSophysa SA · 2007 · Recalled
- 2 generations backK103206 Raumedic- Icp-Monitoring SystemRaumedic AG · 2011
- 1 generation backK112017 Raumedic Icp Monitoring SystemRaumedic AG · 2011
- This deviceK120252 Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012
- Descendant · cites it directly · 4 of its ownK130529 Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013
- Descendant · cites it directly · 1 of its ownK162108 Pressio 2 ICP Monitoring SystemSophysa SA · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK252241 Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026
- Descendant · cites it directly · 0 of its ownK250285 Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R…Raumedic AG · 2025
- Descendant · 2 generations on · 0 of its ownK171666 MPR2 logO DATALOGGERRaumedic AG · 2017
Most influential descendants
Showing 5 of 5 · See all- K130529Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013 · cites it directly4descendants
- K162108Pressio 2 ICP Monitoring SystemSophysa SA · 2017 · cites it directly1descendant
- K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026 · 2 generations on0descendants
- K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…Raumedic AG · 2025 · cites it directly0descendants
- K171666MPR2 logO DATALOGGERRaumedic AG · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914479 | Microsensor Intracranial Pressure Transducer | Codman & Shurtleff, Inc. | 1994 | 3 |
| −3 | K062584 | Pressio Icp Monitoring System | Sophysa SA | 2007 | 2 |
| −2 | K103206 | Raumedic- Icp-Monitoring System | Raumedic AG | 2011 | — |
| −1 | K112017 | Raumedic Icp Monitoring System | Raumedic AG | 2011 | — |
| 0 (this device) | K120252 | Raumedic-Icp-Temp-Monitoring-System | Raumedic AG | 2012 | — |
| +1 | K130529 | Raumedic-Pto-Monitoring-System | Raumedic AG | 2013 | — |
| +1 | K162108 | Pressio 2 ICP Monitoring System | Sophysa SA | 2017 | 3 |
| +2 | K252241 | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | 2026 | — |
| +1 | K250285 | Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R… | Raumedic AG | 2025 | — |
| +2 | 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 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 13.0 · 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? (3)
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 |
|---|---|---|---|
| * | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/)Summary page 3…rature Monitoring Kit, Model 11 0-48T and Camino NeuroCare Intracranial Pressure- Temperature Monitoring Kit, Model 11 0-4HMT, which were cleared to market under 510 (k) K962928 on December 2&~ 1996 and the RAUMEDICO -lOP-Monitoring-System which was cleared to market under 510 (k)K1l03206 on 00~ of March 2… | 1996 |
| * | K103206 | Raumedic- Icp-Monitoring SystemSummary page 2…RAUMEDIC® - spliceable tunnelling sleeve Cl-I (already cleared to market under 510 (k) 1112017) or via a RAUMEDIC@ - BOLT KIT CH5 (already cleared to market under 510 (k)K1 03206). In addition to the catheters used for pressure and temperature monitoring an ICP-TEMP- cable (already cleared to market under 5… | 2011 |
| * | K112017 | Raumedic Icp Monitoring SystemSummary page 3…em which was cleared to market under 510 (k)K1l03206 on 00~ of March 2011 and the RAUMEDIC@ -lOP- Monitoring-Systemn ventricular which was cleared to market under 510 (k)K1 12017 on I11 'of October 2011. In details this means that - the NEUROVEN?-TEMP IFD-S and the NEUROVENr-TEMP IFD-R are sub… | 2011 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K130529 (Raumedic AG, 2013) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K962928.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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® -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.
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/K120252 · printed Nov 3, 2026
Cite this page
510(k) Report. “K120252: Raumedic-Icp-Temp-Monitoring-System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K120252
Report an extraction error
Are you the manufacturer?
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