510(k) · Cleared
Recalled · Class II · 2024Pressio 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 Jul 5, 2007 as substantially equivalent to K945585 (Johnson & Johnson Professionals, Inc., 1995) and 3 other predicates after a 307-day review. Its family tree reaches back 1 generation to 1994. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 5, 2007
- Review
- 307 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 1 generation to K914479 (1994). 4 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK914479 Microsensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. · 1994 · Recalled
- This deviceK062584 Pressio Icp Monitoring SystemSophysa SA · 2007
- Descendant · cites it directly · 7 of its ownK103206 Raumedic- Icp-Monitoring SystemRaumedic AG · 2011
- Descendant · cites it directly · 6 of its ownK112017 Raumedic Icp Monitoring SystemRaumedic AG · 2011
- Descendant · 2 generations on · 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 · cites it directly · 1 of its ownK162108 Pressio 2 ICP Monitoring SystemSophysa SA · 2017 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K103206Raumedic- Icp-Monitoring SystemRaumedic AG · 2011 · cites it directly7descendants
- K112017Raumedic Icp Monitoring SystemRaumedic AG · 2011 · cites it directly6descendants
- K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012 · 2 generations on5descendants
- K130529Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013 · 2 generations on4descendants
- K162108Pressio 2 ICP Monitoring SystemSophysa SA · 2017 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914479 | Microsensor Intracranial Pressure Transducer | Codman & Shurtleff, Inc. | 1994 | 3 |
| 0 (this device) | K062584 | Pressio Icp Monitoring System | Sophysa SA | 2007 | — |
| +1 | K103206 | Raumedic- Icp-Monitoring System | Raumedic AG | 2011 | — |
| +1 | K112017 | Raumedic Icp Monitoring System | Raumedic AG | 2011 | — |
| +2 | 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 |
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 | 2 | 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 13.0 · 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 |
|---|---|---|---|
| * | K945585 | Coman (R) CU-11 Model Number 82-6634Summary page 3…ge 53 3.7 Substantial Equivalence Summary The Pressio® ICP monitoring system is substantially equivalent to the Codman® ICP express monitoring system (K945585, K914479, K991222 and K974088) in terms of intended use, materials, design, function and operating characteristics. The two monit… | 1995 |
| * | K914479 | Microsensor Intracranial Pressure TransducerSummary page 3…= Page 3 === 3.7 Substantial Equivalence Summary The Pressio® ICP monitoring system is substantially equivalent to the Codman® ICP express monitoring system (K945585, K914479, K991222 and K974088) in terms of intended use, materials, design, function and operating characteristics. The two monitoring sys… | 1994 |
| * | K991222 | Codman Microsensor Ventricular Catheter KitSummary page 3…=== 3.7 Substantial Equivalence Summary The Pressio® ICP monitoring system is substantially equivalent to the Codman® ICP express monitoring system (K945585, K914479, K991222 and K974088) in terms of intended use, materials, design, function and operating characteristics. The two monitoring systems util… | 1999 |
| * | K974088 | Codman Intracranial BoltSummary page 3…ubstantial Equivalence Summary The Pressio® ICP monitoring system is substantially equivalent to the Codman® ICP express monitoring system (K945585, K914479, K991222 and K974088) in terms of intended use, materials, design, function and operating characteristics. The two monitoring systems utilize the same… | 1998 |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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?
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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® Ventricular Intracranial Pressure Monitoring Kit with Tunneling, Model PSO-VT, is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage applications.
The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Tunneling, Model PSO-PT, is indicated for use in subdural or parenchymal pressure monitoring.
The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Bolt, Model PSO-PB, is indicated for use in parenchymal pressure monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062584 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062584: Pressio Icp Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062584
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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