Cleared Traditional

RADIONICS XDC EXTERNAL VENTRICULAR CATHETER (K992379) - FDA 510(k) Clearance

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

K992379 · Radionics, Inc. · Neurology device
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Sep 1999
Decision
54d
Days
Class 2
Risk

K992379 is an FDA 510(k) clearance for the RADIONICS XDC EXTERNAL VENTRICULAR CATHETER. 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 September 8, 1999 after a review of 54 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Radionics, Inc. devices

Submission Details

510(k) Number K992379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1999
Decision Date September 08, 1999
Days to Decision 54 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
94d faster than avg
Panel avg: 148d · This submission: 54d
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 75
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K992379.
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