Cleared Traditional

K961013 - DISPOSABLE NEEDLE ELECTRODE

K961013 is the FDA 510(k) clearance for DISPOSABLE NEEDLE ELECTRODE by Medelec Intl. Corp.. It is a Class 2 Neurology device (product code IKT) cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K961013 · Medelec Intl. Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
282d
Days
Class 2
Risk

K961013 is an FDA 510(k) clearance for the DISPOSABLE NEEDLE ELECTRODE. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Medelec Intl. Corp. (England, GB). The FDA issued a Cleared decision on December 20, 1996 after a review of 282 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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 Medelec Intl. Corp. devices

Submission Details

510(k) Number K961013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1996
Decision Date December 20, 1996
Days to Decision 282 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 148d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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 - IKT Electrode, Needle, Diagnostic Electromyograph

Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K961013.
Allergan Botox Needle Electrode
K173815 · Natus Manufacturing Limited · Jun 2018
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
K093825 · Ambu A/S · Jan 2010
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
K071186 · Ambu A/S · Jul 2007
EMG ELECTRODES AND EXTENSION CORDS
K870795 · Nihon Kohden America, Inc. · Mar 1987
MEB-5200
K854664 · Nihon Kohden America, Inc. · Aug 1986