Cleared Traditional

K020907 - NEUROLINE, SUBDERMAL NEEDLE ELECTRODES

K020907 is an FDA 510(k) clearance for NEUROLINE, 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 86-day FDA review.

K020907 · Medicotest A/S · Neurology device
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Jun 2002
Decision
86d
Days
Class 2
Risk

K020907 is an FDA 510(k) clearance for the NEUROLINE, SUBDERMAL NEEDLE ELECTRODES. 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 June 14, 2002 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K020907

510(k) Number K020907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2002
Decision Date June 14, 2002
Days to Decision 86 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
63d faster than avg
Panel avg: 149d · This submission: 86d
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 42
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K020907.
ULTRASHARP CONCENTRIC NEEDLES
K080914 · Rochester Electro Medical, Inc. · Jul 2008
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
K071186 · Ambu A/S · Jul 2007
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
K062437 · Technomed Europe · Feb 2007
STERILE EMG ELECTRODES
K011818 · Nicolet Biomedical, Inc. · Sep 2001
DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
K002992 · Medtronic Functional Diagnostics A/S · Aug 2001
DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
K001869 · Medicotest A/S · Sep 2000
K020907 · NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
Download PDF Medicotest A/S