Sophysa
FDA Regulatory Profile
Sophysa appears in FDA public data with 3 recalls, 13 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1029-2026, Class II) was initiated on November 17, 2025. Its most recent 510(k) clearance was granted on April 10, 2026.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 13
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1029-2026 | Class II | The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor | November 17, 2025 |
| Z-1825-2024 | Class II | The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for mon | April 9, 2024 |
| Z-1826-2024 | Class II | The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for mon | April 9, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252241 | Pressio 3 Multi-parameter Neuromonitoring System | April 10, 2026 |
| K250636 | Sophy Mini Monopressure Valve (SM1) | November 28, 2025 |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | June 20, 2025 |
| K222422 | Polaris Valve Electronic Reading Instrument | February 2, 2023 |
| K162108 | Pressio 2 ICP Monitoring System | April 17, 2017 |
| K141227 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX | April 2, 2015 |
| K091328 | SIPHONX GRAVITATIONAL ANTISIPHON DEVICE | January 22, 2010 |
| K090342 | POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 | August 11, 2009 |
| K062584 | PRESSIO ICP MONITORING SYSTEM | July 5, 2007 |
| K042481 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 | December 14, 2004 |
| K031097 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB | February 26, 2004 |
| K013488 | SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 | March 27, 2002 |
| K992465 | SOPHY SU8 PRESSURE ADJUSTABLE VALVE | September 21, 2000 |