Cleared Traditional

K992465 - SOPHY SU8 PRESSURE ADJUSTABLE VALVE

K992465 is an FDA 510(k) clearance for SOPHY SU8 PRESSURE ADJUSTABLE VALVE, 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 426-day FDA review.

K992465 · Sophysa SA · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
426d
Days
Class 2
Risk

K992465 is an FDA 510(k) clearance for the SOPHY SU8 PRESSURE ADJUSTABLE VALVE. 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 September 21, 2000 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Sophysa SA devices

FDA 510(k) Submission Details - K992465

510(k) Number K992465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1999
Decision Date September 21, 2000
Days to Decision 426 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
278d slower than avg
Panel avg: 148d · This submission: 426d
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 K992465.
CODMAN HAKIM SHUNT SYSTEMS
K020667 · Codman & Shurtleff, Inc. · Mar 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030 · Aesculap, Inc. · Mar 2002
HAKIM PROGRAMMER AND TRANSMITTER
K003564 · Codman & Shurtleff, Inc. · Dec 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226 · Radionics, Inc. · Aug 2000
SIPHONGUARD CSF CONTROL DEVICE
K992173 · Johnson & Johnson Professionals, Inc. · Apr 2000
RADIONICS LUMBOPERITONEAL SHUNT
K000057 · Radionics, Inc. · Mar 2000