Cleared Traditional

K123554 - SHUNTCHECK

K123554 is an FDA 510(k) clearance for SHUNTCHECK, manufactured by Neurodx Development, LLC. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K123554 · Neurodx Development, LLC · Neurology device
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Mar 2013
Decision
108d
Days
Class 2
Risk

K123554 is an FDA 510(k) clearance for the SHUNTCHECK. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Neurodx Development, LLC (Bensalem, US). The FDA issued a Cleared decision on March 7, 2013 after a review of 108 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 Neurodx Development, LLC devices

FDA 510(k) Submission Details - K123554

510(k) Number K123554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2012
Decision Date March 07, 2013
Days to Decision 108 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
40d faster than avg
Panel avg: 148d · This submission: 108d
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 184
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K123554.
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K123524 · Medtronic Neurosurgery · Feb 2013
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K122118 · Codman & Shurtleff, Inc. · Aug 2012
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