Cleared Traditional

K002992 - DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431

K002992 is an FDA 510(k) clearance for DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, manufactured by Medtronic Functional Diagnostics A/S. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K002992 · Medtronic Functional Diagnostics A/S · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
324d
Days
Class 2
Risk

K002992 is an FDA 510(k) clearance for the DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9.... Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Medtronic Functional Diagnostics A/S (Skovlunde, DK). The FDA issued a Cleared decision on August 15, 2001 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medtronic Functional Diagnostics A/S devices

FDA 510(k) Submission Details - K002992

510(k) Number K002992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2000
Decision Date August 15, 2001
Days to Decision 324 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
176d slower than avg
Panel avg: 148d · This submission: 324d
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 37
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K002992.
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
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
K982950 · Chalgren Enterprises, Inc. · Jun 1999
ELECTRODE NEEDLES
K990015 · Technomed Europe · May 1999
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25
K990375 · Medtronic Functional Diagnostics A/S · Mar 1999