Sophysa

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
13
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1029-2026Class IIThe Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure MonitorNovember 17, 2025
Z-1825-2024Class IIThe Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monApril 9, 2024
Z-1826-2024Class IIThe Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monApril 9, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K252241Pressio 3 Multi-parameter Neuromonitoring SystemApril 10, 2026
K250636Sophy Mini Monopressure Valve (SM1)November 28, 2025
K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJune 20, 2025
K222422Polaris Valve Electronic Reading InstrumentFebruary 2, 2023
K162108Pressio 2 ICP Monitoring SystemApril 17, 2017
K141227POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONXApril 2, 2015
K091328SIPHONX GRAVITATIONAL ANTISIPHON DEVICEJanuary 22, 2010
K090342POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400August 11, 2009
K062584PRESSIO ICP MONITORING SYSTEMJuly 5, 2007
K042481POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400December 14, 2004
K031097POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVBFebruary 26, 2004
K013488SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8March 27, 2002
K992465SOPHY SU8 PRESSURE ADJUSTABLE VALVESeptember 21, 2000