510(k) · Cleared
ClearedRaumedic-Pto-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 25, 2013 as substantially equivalent to K980380 (Diametrics Medical, Ltd., 1999) and 3 other predicates after a 238-day review. Its family tree reaches back 5 generations to 1994. 4 later devices descend from it.
- Decided
- Oct 25, 2013
- Review
- 238 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K914479 (1994). 18 ancestors in all, the oldest K813459 (1982). 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK914479 Microsensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. · 1994 · Recalled
- 4 generations backK062584 Pressio Icp Monitoring SystemSophysa SA · 2007 · Recalled
- 3 generations backK103206 Raumedic- Icp-Monitoring SystemRaumedic AG · 2011
- 2 generations backK112017 Raumedic Icp Monitoring SystemRaumedic AG · 2011
- 1 generation backK120252 Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012
- This deviceK130529 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 · cites it directly · 0 of its ownK171666 MPR2 logO DATALOGGERRaumedic AG · 2017
Most influential descendants
Showing 4 of 4 · See all- 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914479 | Microsensor Intracranial Pressure Transducer | Codman & Shurtleff, Inc. | 1994 | 3 |
| −4 | K062584 | Pressio Icp Monitoring System | Sophysa SA | 2007 | 2 |
| −3 | K103206 | Raumedic- Icp-Monitoring System | Raumedic AG | 2011 | — |
| −2 | K112017 | Raumedic Icp Monitoring System | Raumedic AG | 2011 | — |
| −1 | K120252 | Raumedic-Icp-Temp-Monitoring-System | Raumedic AG | 2012 | — |
| 0 (this device) | 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 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K980380 | Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter…Summary page 3…RAUMEDICO - PTO-Monitoring-Systemn is substantially equivalent to the DIAMETRIC MEDICAL LTD. NEUROTRENO MULTIPARAMETER SENSOR which was cleared for market under 51 0(k) K980380 on 1 4 h of July 1999, the LICOX Brain Oxygen Monitoring System which was cleared for market under 51 0(k) K(002765 on 2 4 h of N… | 1999 |
| * | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer…Summary page 9…*AMEI Lifeline to Health Table 3: Comparison to Predicate LICOX Brain Oxygen Monitoring System (K002 765) Feature RAUMEDICO PTO- RAUMEDICw ICP- LICOX Brain Oxygen SE? MONIT… | 2000 |
| * | K120252 | Raumedic-Icp-Temp-Monitoring-SystemSummary page 4…___ Page 3 of 14 & RAUMEDIC — Lifeline to Health — Table 1: Comparison to Predicate RAUMEDIC® ICP-TEMP- MONITORING- SYSTEM (K120252) RAUMEDIC® ICP-TEMP- RAUMEDIC® PTO- Feature MONITORING- SYSTEM SE? MONITORING- SYSTEM (K120252) NEUROVENT®-PTO, NEUROVENT>-P-T… | 2012 |
| * | K103206 | Raumedic- Icp-Monitoring SystemSummary page 3…ORING-SYSTEM which was cleared for market under 51 0(k) K(120252 on 11 "hof April 2012 and the RAUMEDIC® lOP-MONITORING-SYSTEM which was cleared for market under 51 0(k) K1 03206 on 0 4 h of March 2011. For further information see device comparison tables below. Device #:_______… | 2011 |
What descends from it? (4)
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 19 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 18 ancestors have a recall of any class.
- Of its descendants, K162108 (Sophysa SA, 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K980380.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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® - PTO-Monitoring-System measures intracranial pressure, temperature and oxygen and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. RAUMEDIC® - PTO-Monitoring-System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia or ischemia is a concern.
Use of the parenchymal intracranial pressure monitoring kit with bolt is indicated for children who are at least one year old.
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/K130529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130529: Raumedic-Pto-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/K130529
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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