# K252241: Pressio 3 Multi-parameter Neuromonitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Sophysa
- Decided: Apr 10, 2026 after 267 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K914479 (1994). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162108: Pressio 2 ICP Monitoring System, Sophysa SA (2017) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K252241
Methodology: https://510kreport.com/methodology