510(k) · Cleared
Recalled · Class II · 2025Pressio 2 ICP Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sophysa SA · GWM Device, Monitoring, Intracranial Pressure
Cleared on Apr 17, 2017 as substantially equivalent to K121573 (Intrgra Lifesciences Corporation, 2012) and 4 other predicates after a 262-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Apr 17, 2017
- Review
- 262 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 6 generations to K914479 (1994). 22 ancestors in all, the oldest K813459 (1982). 1 later device descends from it, 1 citing it directly.
- 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 deviceK162108 Pressio 2 ICP Monitoring SystemSophysa SA · 2017
- Descendant · cites it directly · 0 of its ownK252241 Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026
Most influential descendants
Showing 1 of 1 · See all- K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026 · cites it directly0descendants
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) | K162108 | Pressio 2 ICP Monitoring System | Sophysa SA | 2017 | — |
| +1 | K252241 | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | 2026 | — |
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 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K121573 | Integra Camino Icp MonitorSummary page 4…Regulation & Review Panel number Product Code Integra® Camino® ICP monitor K121573 Ear Nose & 21 CFR 882.16… | 2012 |
| * | K102875 | Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post Craniotomy…Summary page 4…21 CFR 882.1620 Throat Camino Parenchymal Bolt GWM ICP Monitoring catheter – K102875 Ear Nose & 110-4B… | 2010 |
| * | K130529 | Raumedic-Pto-Monitoring-SystemSummary page 4…Ear Nose & 110-4B Throat Raumedic® Neurovent®-PTO 2L K130529 21 CFR 882.1620 Neurology Neurovent®-PTO GWM… | 2013 |
| * | K120252 | Raumedic-Icp-Temp-Monitoring-SystemSummary page 4…30529 21 CFR 882.1620 Neurology Neurovent®-PTO GWM Neurovent®-TEMP IFD-S K120252 21 CFR 882.1620 Ear Nose & GWM… | 2012 |
| * | K062584 | Pressio Icp Monitoring SystemSummary page 4…2.1620 Ear Nose & GWM Throat Sophysa® Sophysa® - PSO-PB K062584 21 CFR 882.1620 Neurology Sophysa® - PSO-PT Sophysa® - PSO-VT Device: The… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252241 | Pressio 3 Multi-parameter Neuromonitoring System | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2025 | Class II | Z-1029-2026 | Software design | Customer complaints of Pressio monitor rebooting. |
| Apr 9, 2024 | Class II | Z-1825-2024 | Process change control | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the… |
| Apr 9, 2024 | Class II | Z-1826-2024 | Process change control | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the… |
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 3.5 years on median.
- 8 of the 22 ancestors have a recall of any class.
- Of its descendants, K252241 (Sophysa, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121573.
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 Pressio® 2 Intracranial Pressure Monitoring system is indicated for continuous invasive monitoring of intracranial pressure by trained personnel of (neuro) intensive care units and neurosurgery departments. Depending the type of catheter used, the Pressio® 2 ICP Monitor can also display the intracranial temperature. According to the clinical situation, users choose the appropriate Pressio® catheters: - Pressio® kit for monitoring intracranial…
Read the full statement (202 words)
The Pressio® 2 Intracranial Pressure Monitoring system is indicated for continuous invasive monitoring of intracranial pressure by trained personnel of (neuro) intensive care units and neurosurgery departments.
Depending the type of catheter used, the Pressio® 2 ICP Monitor can also display the intracranial temperature.
According to the clinical situation, users choose the appropriate Pressio® catheters:
- Pressio® kit for monitoring intracranial parenchymal pressure and temperature with bolt (PSO-PBT) indicated for use in parenchymal pressure and temperature monitoring.
- Pressio® kit for monitoring intracranial parenchymal pressure and temperature with tunneling (PSO-PTT) indicated for use in parenchymal pressure and temperature monitoring.
- Pressio® kit for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure and temperature monitoring and cerebrospinal fluid drainage application.
The following Pressio® kits for Intracranial Pressure Monitoring are also compatible with the Pressio® 2 ICP Monitor:
- Pressio® kit for monitoring intracranial parenchymal pressure with bolt (PSO-PB) indicated for use in parenchymal pressure monitoring
- Pressio® kit for monitoring intracranial parenchymal pressure with tunneling (PSO-PT) indicated for use in parenchymal pressure monitoring.
- Pressio® kit for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162108: Pressio 2 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/K162108
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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