510(k) · Cleared
ClearedPressio 3 Multi-parameter Neuromonitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sophysa · GWM Device, Monitoring, Intracranial Pressure
Cleared on Apr 10, 2026 as substantially equivalent to K162108 (Sophysa SA, 2017) after a 267-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Apr 10, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K914479 (1994). 23 ancestors in all, the oldest K813459 (1982). No later device cites it as a predicate yet.
- Root · 7 generations backK914479 Microsensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. · 1994 · Recalled
- 6 generations backK062584 Pressio Icp Monitoring SystemSophysa SA · 2007 · Recalled
- 5 generations backK103206 Raumedic- Icp-Monitoring SystemRaumedic AG · 2011
- 4 generations backK112017 Raumedic Icp Monitoring SystemRaumedic AG · 2011
- 3 generations backK120252 Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012
- 2 generations backK130529 Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013
- 1 generation backK162108 Pressio 2 ICP Monitoring SystemSophysa SA · 2017 · Recalled
- This deviceK252241 Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914479 | Microsensor Intracranial Pressure Transducer | Codman & Shurtleff, Inc. | 1994 | 3 |
| −6 | K062584 | Pressio Icp Monitoring System | Sophysa SA | 2007 | 2 |
| −5 | K103206 | Raumedic- Icp-Monitoring System | Raumedic AG | 2011 | — |
| −4 | K112017 | Raumedic Icp Monitoring System | Raumedic AG | 2011 | — |
| −3 | K120252 | Raumedic-Icp-Temp-Monitoring-System | Raumedic AG | 2012 | — |
| −2 | K130529 | Raumedic-Pto-Monitoring-System | Raumedic AG | 2013 | — |
| −1 | K162108 | Pressio 2 ICP Monitoring System | Sophysa SA | 2017 | 3 |
| 0 (this device) | 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 |
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 K250285 Neurovent-P (092946-003); Neurovent…score 11.4 · 6 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 |
|---|---|---|---|
| * | K162108 | Pressio 2 ICP Monitoring SystemSummary page 5…21 CFR 882.1620 Device Class: 2 Product Code: GWM Predicate Device Predicate: Pressio® 2 ICP Monitoring System (K162108) Device Description The Pressio® 3 Monitor is used in patients requiring continuous invasive monitoring of intracranial pressur… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 9 of the 23 ancestors have a recall of any class.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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® 3 System is indicated for continuous invasive monitoring of intracranial pressure by trained personnel in neuro-intensive care units and neurosurgical departments. Depending on the type of catheter being used, the Pressio® 3 Monitor can also display the intracranial temperature. According to the clinical situation, you can select the appropriate Pressio® catheter: – Pressio® kit for monitoring intracranial parenchymal pressure and…
Read the full statement (199 words)
The Pressio® 3 System is indicated for continuous invasive monitoring of intracranial pressure by trained personnel in neuro-intensive care units and neurosurgical departments.
Depending on the type of catheter being used, the Pressio® 3 Monitor can also display the intracranial temperature. According to the clinical situation, you can select the appropriate Pressio® catheter:
– 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® 3 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/K252241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252241: Pressio 3 Multi-parameter Neuromonitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252241
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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