Cleared Traditional

K130816 - INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)

K130816 is an FDA 510(k) clearance for INTERX STERILE SELF-ADHESIVE DUAL ELECT..., 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 88-day FDA review.

K130816 · Neuro Resource Group, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
88d
Days
Class 2
Risk

K130816 is an FDA 510(k) clearance for the INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE). 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 June 21, 2013 after a review of 88 days - a notably fast clearance cycle.

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: 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 Neuro Resource Group, Inc. devices

FDA 510(k) Submission Details - K130816

510(k) Number K130816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2013
Decision Date June 21, 2013
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 K130816.
HIVOX SELF ADHESIVE ELECTRODE GEL PADS
K131720 · Hivox Biotek, Inc. · Jul 2014
SKINTACT
K140340 · Leonhard Lang GmbH · May 2014
DYNATRON PELTIER THERMOSTIM PROBE
K132057 · Dynatronics Corp. · Jan 2014
MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
K130287 · Rhythmlink International, LLC · May 2013
PMT TRUSCAN SURFACE ELECTRODE
K122376 · Pmt Corp. · Dec 2012
SENSUS ELECTRODE
K121816 · Neurometrix, Inc. · Nov 2012