510(k) · Cleared
ClearedRaumedic Icp 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 Oct 11, 2011 as substantially equivalent to K103206 (Raumedic AG, 2011) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it.
- Decided
- Oct 11, 2011
- Review
- 89 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K914479 (1994). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK914479 Microsensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. · 1994 · Recalled
- 2 generations backK062584 Pressio Icp Monitoring SystemSophysa SA · 2007 · Recalled
- 1 generation backK103206 Raumedic- Icp-Monitoring SystemRaumedic AG · 2011
- This deviceK112017 Raumedic Icp Monitoring SystemRaumedic AG · 2011
- Descendant · cites it directly · 5 of its ownK120252 Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012
- Descendant · 2 generations on · 4 of its ownK130529 Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013
- Descendant · 2 generations on · 1 of its ownK162108 Pressio 2 ICP Monitoring SystemSophysa SA · 2017 · Recalled
- Descendant · 3 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012 · cites it directly5descendants
- K130529Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013 · 2 generations on4descendants
- K162108Pressio 2 ICP Monitoring SystemSophysa SA · 2017 · 2 generations on1descendant
- K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026 · 3 generations on0descendants
- K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…Raumedic AG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914479 | Microsensor Intracranial Pressure Transducer | Codman & Shurtleff, Inc. | 1994 | 3 |
| −2 | K062584 | Pressio Icp Monitoring System | Sophysa SA | 2007 | 2 |
| −1 | K103206 | Raumedic- Icp-Monitoring System | Raumedic AG | 2011 | — |
| 0 (this device) | K112017 | Raumedic Icp Monitoring System | Raumedic AG | 2011 | — |
| +1 | K120252 | Raumedic-Icp-Temp-Monitoring-System | Raumedic AG | 2012 | — |
| +2 | K130529 | Raumedic-Pto-Monitoring-System | Raumedic AG | 2013 | — |
| +2 | K162108 | Pressio 2 ICP Monitoring System | Sophysa SA | 2017 | 3 |
| +3 | K252241 | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | 2026 | — |
| +1 | K250285 | Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R… | Raumedic AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K103206 | Raumedic- Icp-Monitoring SystemSummary page 2…ceable tunneling sleeve 0H 12 and a stylet. In addition to the catheters used for pressure monitoring a zero point module NPS2 x (already cleared to market under 510 (k)K1 03206) is needed. "x"depends on the type of patient monitor available inthe hospital - there are 20 different references. To the equipm… | 2011 |
| * | K062584 | Pressio Icp Monitoring SystemSummary page 3…nitoring-System which was cleared to market under 510 (k)K1032068on 04' of March 2011 and the Pressico ICP MONITORING SYSTEM, which was cleared to market under 610 (k) K(062584 on July 5 2007. Fur further information see device comparison tables attached. Based on performance testing and the available in… | 2007 |
What descends from it? (6)
2 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 17 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K120252 (Raumedic AG, 2012) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K103206.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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-Monitoring-System ventricular is Indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications.
Use of the 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 as stated in the FDA summary.
https://510kreport.com/device/K112017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112017: Raumedic Icp Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112017
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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