Cleared Traditional

K042481 - POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM

K042481 is an FDA 510(k) clearance for POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, manufactured by Sophysa SA. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K042481 · Sophysa SA · Neurology device
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Dec 2004
Decision
92d
Days
Class 2
Risk

K042481 is an FDA 510(k) clearance for the POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Sophysa SA (Wellesley, US). The FDA issued a Cleared decision on December 14, 2004 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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. Standard predicate reliance. 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 - K042481

510(k) Number K042481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date December 14, 2004
Days to Decision 92 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
56d faster than avg
Panel avg: 148d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - JXG Shunt, Central Nervous System And Components

All 181
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K042481.
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K042198 · Medtronic Neurosurgery · Sep 2004
MEDTRONIC PS MEDICAL STRATA VALVE
K040943 · Medtronic Neurosurgery · Jun 2004