Cleared Traditional

K001869 - DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE

K001869 is an FDA 510(k) clearance for DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELEC..., manufactured by Medicotest A/S. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K001869 · Medicotest A/S · Neurology device
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Sep 2000
Decision
90d
Days
Class 2
Risk

K001869 is an FDA 510(k) clearance for the DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Medicotest A/S (Washington, US). The FDA issued a Cleared decision on September 18, 2000 after a review of 90 days - within the typical 510(k) review window.

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 Medicotest A/S devices

FDA 510(k) Submission Details - K001869

510(k) Number K001869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2000
Decision Date September 18, 2000
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 26
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K001869.
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
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K091056 · Rhythmlink International, LLC · Jun 2009
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
K071186 · Ambu A/S · Jul 2007
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
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SLE EMG ELECTRODES AND ACCESSORIES
K981004 · Specialized Laboratory Equipment, Ltd. · Oct 1998
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K973442 · Medelec, Inc. D.B.A. Teca Corp. · Nov 1997