510(k) Report

FDA applicant

Sophysa SA

Orsay, FR13 decisions2000–20263 recalls

FDA records 13 decisions for Sophysa SA (Orsay, FR) from 2000 to 2026: 13 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and GWM (Device, Monitoring, Intracranial Pressure). Since 2016 its 510(k)s took a median of 265 days from receipt to decision, against 195 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 7 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Sophysa”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Sophysa SA’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007: 12009: 12010: 12015: 12017: 12023: 12025: 22026 (partial year): 1
2007high 2 (2025) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2025

2024: 22025: 1
2007high 2 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sophysa SA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JXGShunt, Central Nervous System And Components10decisions
  • GWMDevice, Monitoring, Intracranial Pressure3decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 265 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 195 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 21 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062584Pressio Icp Monitoring SystemSophysa SA · 20073cite it
  • K141227Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with SiphonxSophysa SA · 20152cite it
  • K992465Sophy SU8 Pressure Adjustable ValveSophysa SA · 20002cite it
  • K013488Sophy Pressure Adjustable Valve System Model SM8Sophysa SA · 20021cites it
  • K090342Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400Sophysa SA · 20091cites it
  • K031097Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA · 20041cites it

What has FDA decided for it lately?

  • K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026
  • K250636Sophy Mini Monopressure Valve (SM1)Sophysa · 2025
  • K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersSophysa · 2025
  • K222422Polaris Valve Electronic Reading InstrumentSophysa · 2023
  • K162108Pressio 2 ICP Monitoring SystemSophysa SA · 20173 recalls
  • K141227Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with SiphonxSophysa SA · 2015
  • K091328Siphonx Gravitational Antisiphon DeviceSophysa SA · 2010
  • K090342Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400Sophysa SA · 2009

All 9 as Sophysa SA →All 4 as Sophysa →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K162108The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure MonitorNov 17, 2025Class II
  • K162108The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is…Apr 9, 2024Class II
  • K162108The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is…Apr 9, 2024Class II