Pressio 3 Multi-parameter Neuromonitoring System
FDA 510(k) K252241 · Sophysa
510(k) numberK252241
Submission
- Device name
- Pressio 3 Multi-parameter Neuromonitoring System
- Applicant
- Sophysa
Orsay, FR - Received
- July 17, 2025
- Decision date
- April 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K200456 | Becker External Drainage and Monitoring SystemGWM · Special | Medtronic, Inc. | 03/26/2020SE |
| K182073 | BcSs-PICNI-2000 SensorGWM · Traditional | Braincare Desenvolvimento E Inovacao Tecnologica… | 10/17/2019SE |
| K183406 | CereLink ICP Monitor, CereLink ICP Extension CableGWM · Special | Integra Lifesciences Corp. | 01/11/2019SE |
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| K222422 | Polaris Valve Electronic Reading InstrumentJXG · Traditional | 02/02/2023SE |
| K162108 | Pressio 2 ICP Monitoring SystemGWM · Traditional | 04/17/2017SE |
| K141227 | Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with SiphonxJXG · Traditional | 04/02/2015SE |
| K091328 | Siphonx Gravitational Antisiphon DeviceJXG · Traditional | 01/22/2010SE |
| K090342 | Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400JXG · Traditional | 08/11/2009SE |
| K062584 | Pressio Icp Monitoring SystemGWM · Traditional | 07/05/2007SE |
| K042481 | Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400JXG · Traditional | 12/14/2004SE |
| K031097 | Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBJXG · Traditional | 02/26/2004SE |
Questions and answers
When was Pressio 3 Multi-parameter Neuromonitoring System cleared by the FDA?
Pressio 3 Multi-parameter Neuromonitoring System (K252241) received a 510(k) decision of Substantially Equivalent on April 10, 2026, 267 days after the submission was received.
What is the product code of K252241?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.