Cleared Traditional

K062584 - PRESSIO ICP MONITORING SYSTEM

K062584 is an FDA 510(k) clearance for PRESSIO ICP MONITORING SYSTEM, manufactured by Sophysa SA. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K062584 · Sophysa SA · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K062584

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.

GWM Device Classification - Class 2, Special Controls

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 43
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K062584.
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