# K162108: Pressio 2 ICP Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Sophysa SA
- Decided: Apr 17, 2017 after 262 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K914479 (1994). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121573: Integra Camino Icp Monitor, Intrgra Lifesciences Corporation (2012) Summary page 4.
- K102875: Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post Craniotomy Subdural Pressure Monitoring Kit; C, Integra LifeSciences Corporation (2010) Summary page 4.
- K130529: Raumedic-Pto-Monitoring-System, Raumedic AG (2013) Summary page 4.
- K120252: Raumedic-Icp-Temp-Monitoring-System, Raumedic AG (2012) Summary page 4.
- K062584: Pressio Icp Monitoring System, Sophysa SA (2007) Summary page 4.

## Most influential descendants
- K252241: Pressio 3 Multi-parameter Neuromonitoring System (2026), 0 descendants of its own

## Recalls of this device
- Nov 17, 2025 · Class II · Z-1029-2026: Customer complaints of Pressio monitor rebooting.
- 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® 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.

Source page: https://510kreport.com/device/K162108
Methodology: https://510kreport.com/methodology