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 Mar 4, 2011 as substantially equivalent to K062584 (Sophysa SA, 2007) after a 123-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it.
- Decided
- Mar 4, 2011
- Review
- 123 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914479 (1994). 5 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK914479 Microsensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. · 1994 · Recalled
- 1 generation backK062584 Pressio Icp Monitoring SystemSophysa SA · 2007 · Recalled
- This deviceK103206 Raumedic- Icp-Monitoring SystemRaumedic AG · 2011
- Descendant · cites it directly · 6 of its ownK112017 Raumedic Icp Monitoring SystemRaumedic AG · 2011
- Descendant · cites it directly · 5 of its ownK120252 Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012
- Descendant · cites it directly · 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K112017Raumedic Icp Monitoring SystemRaumedic AG · 2011 · cites it directly6descendants
- K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012 · cites it directly5descendants
- K130529Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013 · cites it directly4descendants
- K162108Pressio 2 ICP Monitoring SystemSophysa SA · 2017 · 2 generations on1descendant
- K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914479 | Microsensor Intracranial Pressure Transducer | Codman & Shurtleff, Inc. | 1994 | 3 |
| −1 | K062584 | Pressio Icp Monitoring System | Sophysa SA | 2007 | 2 |
| 0 (this device) | K103206 | Raumedic- Icp-Monitoring System | Raumedic AG | 2011 | — |
| +1 | K112017 | Raumedic Icp Monitoring System | Raumedic AG | 2011 | — |
| +1 | K120252 | Raumedic-Icp-Temp-Monitoring-System | Raumedic AG | 2012 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K062584 | Pressio Icp Monitoring SystemSummary page 3…itoring-System is substantially equivalent to those of a legally marketed predicate device, the Pressio@ lOP MONITORING SYSTEM, which was cleared to market under 510 (k) K062584 on July 5. See device comparison table attached. Based on performance testing and the available information concerning the refe… | 2007 |
What descends from it? (7)
4 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 13.3 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K112017 (Raumedic AG, 2011) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K062584.
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 RAUMEDICO -ICP-Manitoring-Systemn is indicated for use in parenchymal pressure monitoring.
Use of the parenchymal intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old.
The RAUMEDIC® precision pressure 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/K103206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103206: 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/K103206
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