Cleared Traditional

K062584 - PRESSIO ICP MONITORING SYSTEM (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062584 · Sophysa SA · Neurology device
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Jul 2007
Decision
307d
Days
Class 2
Risk

K062584 is an FDA 510(k) clearance for the PRESSIO ICP MONITORING SYSTEM. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Sophysa SA (Dana Point, US). The FDA issued a Cleared decision on July 5, 2007 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sophysa SA devices

Submission Details

510(k) Number K062584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2006
Decision Date July 05, 2007
Days to Decision 307 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 148d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWM Device, Monitoring, Intracranial Pressure

All 104
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K062584.
Pressio 3 Multi-parameter Neuromonitoring System
K252241 · Sophysa · Apr 2026
NEUROVENT-P (092946-003)
K250285 · Raumedic AG · Aug 2025
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
K240821 · Braincare Desenvolvimento E Inova??o Tecnol?gica S.A. · Jul 2024
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K232890 · Integra Lifesciences Production Corporation · Feb 2024
B4C System
K201989 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Oct 2021
CereLink ICP Monitor
K210993 · Integra Lifesciences Production Corporation · Apr 2021