Cleared Traditional

K053626 - INTERX500 FLEXIBLE ARRAY ELECTRODE

K053626 is an FDA 510(k) clearance for INTERX500 FLEXIBLE ARRAY ELECTRODE, manufactured by Neuro Resource Group, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K053626 · Neuro Resource Group, Inc. · Neurology device
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Mar 2006
Decision
91d
Days
Class 2
Risk

K053626 is an FDA 510(k) clearance for the INTERX500 FLEXIBLE ARRAY ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Neuro Resource Group, Inc. (Plano, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Neuro Resource Group, Inc. devices

FDA 510(k) Submission Details - K053626

510(k) Number K053626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2005
Decision Date March 29, 2006
Days to Decision 91 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
57d faster than avg
Panel avg: 148d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 227
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K053626.
BIS BILATERAL SENSOR
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RHYTHMLINK DISC ELECTRODES
K061148 · Rhythmlink International, LLC · May 2006
CUTANEOUS ELECTRODE
K052188 · Rhythmlink International, LLC · Aug 2005
AMBU NEUROLINE GROUND
K051529 · Ambu, Inc. · Aug 2005
PROTENS ELECTRODE
K042301 · Bio Protech, Inc. · Sep 2004