# K062584: Pressio Icp Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Sophysa SA
- Decided: Jul 5, 2007 after 307 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914479 (1994). 4 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945585: Coman (R) CU-11 Model Number 82-6634, Johnson & Johnson Professionals, Inc. (1995) Summary page 3.
- K914479: Microsensor Intracranial Pressure Transducer, Codman & Shurtleff, Inc. (1994) Summary page 3.
- K991222: Codman Microsensor Ventricular Catheter Kit, Johnson & Johnson Professionals, Inc. (1999) Summary page 3.
- K974088: Codman Intracranial Bolt, Johnson & Johnson Professionals, Inc. (1998) Summary page 3.

## Most influential descendants
- K103206: Raumedic- Icp-Monitoring System (2011), 7 descendants of its own
- K112017: Raumedic Icp Monitoring System (2011), 6 descendants of its own
- K120252: Raumedic-Icp-Temp-Monitoring-System (2012), 5 descendants of its own
- K130529: Raumedic-Pto-Monitoring-System (2013), 4 descendants of its own
- K162108: Pressio 2 ICP Monitoring System (2017), 1 descendant of its own

## Recalls of this device
- Apr 9, 2024 · Class II · Z-1825-2024: 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 ri
- Apr 9, 2024 · Class II · Z-1826-2024: 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 ri

## Indications for use
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.

Source page: https://510kreport.com/device/K062584
Methodology: https://510kreport.com/methodology