Cleared Traditional

K990015 - ELECTRODE NEEDLES

K990015 is an FDA 510(k) clearance for ELECTRODE NEEDLES, manufactured by Technomed Europe. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K990015 · Technomed Europe · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
143d
Days
Class 2
Risk

K990015 is an FDA 510(k) clearance for the ELECTRODE NEEDLES. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Technomed Europe (6191 Bg Beek, NL). The FDA issued a Cleared decision on May 27, 1999 after a review of 143 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 Technomed Europe devices

FDA 510(k) Submission Details - K990015

510(k) Number K990015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1999
Decision Date May 27, 1999
Days to Decision 143 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 148d · This submission: 143d
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 33
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K990015.
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
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25
K990375 · Medtronic Functional Diagnostics A/S · Mar 1999
SLE EMG ELECTRODES AND ACCESSORIES
K981004 · Specialized Laboratory Equipment, Ltd. · Oct 1998
TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K973442 · Medelec, Inc. D.B.A. Teca Corp. · Nov 1997