Cleared Traditional

K961013 - DISPOSABLE NEEDLE ELECTRODE

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

K961013 · Medelec Intl. Corp. · Neurology device
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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

FDA 510(k) Submission Details - K961013

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
Combination Product No
PCCP Authorized No
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.

IKT Device Classification - Class 2, Special Controls

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

All 34
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K961013.
TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K973442 · Medelec, Inc. D.B.A. Teca Corp. · Nov 1997
TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES
K973444 · Medelec, Inc. D.B.A. Teca Corp. · Nov 1997
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
K973529 · Medicotest A/S · Nov 1997
RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP
K960591 · Chalgren Enterprises, Inc. · Jun 1996
DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
K955335 · Chalgren Enterprises, Inc. · Jan 1996
RE-USABLE MONOPOLAR NEEDLE
K953886 · Chalgren Enterprises, Inc. · Oct 1995