Cleared Traditional

XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (K992226) - FDA 510(k) Clearance

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

K992226 · Radionics, Inc. · Neurology device
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Aug 2000
Decision
399d
Days
Class 2
Risk

K992226 is an FDA 510(k) clearance for the XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 399 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: 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 Radionics, Inc. devices

Submission Details

510(k) Number K992226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1999
Decision Date August 04, 2000
Days to Decision 399 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
251d slower than avg
Panel avg: 148d · This submission: 399d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 76
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K992226.
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · Aesculap, Inc. · Jun 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K030698 · Aesculap, Inc. · Mar 2003
AESCULAP -MIETHKE SHUNT SYSTEM
K011030 · Aesculap, Inc. · Mar 2002
SIPHONGUARD CSF CONTROL DEVICE
K992173 · Johnson & Johnson Professionals, Inc. · Apr 2000
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K980778 · Johnson & Johnson Professionals, Inc. · Jul 1998
HAKIM PROGRAMMABLE VALVE SYSTEM
K974739 · Johnson & Johnson Professionals, Inc. · Jul 1998