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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 149d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00583336 Unknown Interventional Industry-sponsored

Physician Preference Study of ShuntCheck - Madsen

Physician Preference Study of the Utility of ShuntCheck to Detect Cerebrospinal Fluid (CSF) in Patients With Ventriculo-Peritoneal CSF Shunts

200
Patients (est.)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied CSF Flow Through the Shunt of a Hydrocephalus Patient
Study design Single group
Eligibility All sexes
Principal investigator Joseph R Madsen, MD
Sponsor NeuroDx Development (industry)
Started 2007-09-01 → Primary completion 2015-07-01 → Completed 2015-09-01
Primary outcome
ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested
Secondary outcome
ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction
View full study on ClinicalTrials.gov

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 248
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K123554.
Codman Certas Plus Programmable Valve
K143111 · Medos International SARL · Feb 2015
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
K140722 · Integra LifeSciences Corporation · Jan 2015
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
K121248 · Moller Medical GmbH · Dec 2013
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K123524 · Medtronic Neurosurgery · Feb 2013
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
K122118 · Codman & Shurtleff, Inc. · Aug 2012
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
K120559 · Aesculap, Inc. · May 2012
K123554 · SHUNTCHECK
Download PDF FDA Summary Neurodx Development, …