Pressio 3 Multi-parameter Neuromonitoring System— 510(k) K252241
Substantially EquivalentSophysa
FDA 510(k) clearance K252241 for Pressio 3 Multi-parameter Neuromonitoring System, Substantially Equivalent on 2026-04-10. Applicant: Sophysa. Device class: 2.
Summary
The Pressio 3 Multi-parameter Neuromonitoring System is filed under GWM, intracranial pressure monitoring devices. ICP monitoring is standard in neurocritical care after traumatic brain injury and hemorrhage. "Multi-parameter" suggests it measures more than pressure, but the record doesn't list what else.
Class II, 21 CFR 882.1620. The Neurology panel reviewed it as a Traditional 510(k).
Sophysa filed from Orsay, France. The company makes neurosurgical hardware, including ICP monitors and shunt systems. Review took 267 days (July 17, 2025 to April 10, 2026).
Clearance details
- Applicant
- Sophysa
- Product code
- Code GWM
- Device class
- Class 2
- Regulation
- 21 CFR 882.1620
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orsay, FR
Recent devices under product code GWM
view allMore clearances from Sophysa
view allAdverse events under product code GWM
product code GWM- Death
- 21
- Injury
- 732
- Malfunction
- 2,063
- Other
- 1
- Total
- 2,817
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.