Product Code: IKT FDA class 2 21 CFR 890.1385

Electrode, Needle, Diagnostic Electromyograph

Physical Medicine

A Needle Electrode for Diagnostic Electromyograph is a fine, disposable or reusable needle-type electrode inserted into skeletal muscle tissue to detect and record electrical signals during electromyographic examination, used in the diagnosis of neuromuscular diseases and nerve injuries. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IKT, regulated under 21 CFR 890.1385, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.

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FEI Numbers

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Basic Information

Product Code: IKT
Device Class: FDA class 2
Regulation Number: 890.1385
Medical Specialty: Physical Medicine
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 43 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253581	Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)	Mar 15, 2026	Substantially Equivalent	Technomed Europe
K173815	Allergan Botox Needle Electrode	Jun 29, 2018	Substantially Equivalent	Natus Manufacturing Limited
K161430	Myoject Luer Lock Needle Electrode	Mar 02, 2017	Substantially Equivalent	Natus Manufacturing Limited
K152984	Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes	Jun 03, 2016	Substantially Equivalent	Bio Protech, Inc.
K143433	Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm	Aug 28, 2015	Substantially Equivalent	Natus Manufacturing Limited
K120342	EMG RECORDING ELECTRODE ASSEMBLY	Jun 22, 2012	Substantially Equivalent	Rhythmlink International, LLC
K112034	TECA ELITE DISPOSABLE CONCENTRIC NEEDLES	Aug 12, 2011	Substantially Equivalent	Carefusion 209, Inc.
K111131	TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES	Jun 17, 2011	Substantially Equivalent	Carefusion 209, Inc.
K092973	DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE	Oct 07, 2010	Substantially Equivalent	Bionen S.A.S.
K093825	AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE	Jan 13, 2010	Substantially Equivalent	Ambu A/S
K091410	DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,	Aug 11, 2009	Substantially Equivalent	Spes Medica Srl
K091056	RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R	Jun 23, 2009	Substantially Equivalent	Rhythmlink International, LLC
K091055	RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R	Jun 23, 2009	Substantially Equivalent	Rhythmlink International, LLC
K080914	ULTRASHARP CONCENTRIC NEEDLES	Jul 15, 2008	Substantially Equivalent	Rochester Electro Medical, Inc.
K071186	MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE	Jul 30, 2007	Substantially Equivalent	Ambu A/S
K062437	DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED	Feb 16, 2007	Substantially Equivalent	Technomed Europe
K020907	NEUROLINE, SUBDERMAL NEEDLE ELECTRODES	Jun 14, 2002	Substantially Equivalent	Medicotest A/S
K011818	STERILE EMG ELECTRODES	Sep 06, 2001	Substantially Equivalent	Nicolet Biomedical, Inc.
K002992	DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431	Aug 15, 2001	Substantially Equivalent	Medtronic Functional Diagnostics A/S
K001869	DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE	Sep 18, 2000	Substantially Equivalent	Medicotest A/S
K982950	FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550	Jun 22, 1999	Substantially Equivalent	Chalgren Enterprises, Inc.
K990015	ELECTRODE NEEDLES	May 27, 1999	Substantially Equivalent	Technomed Europe
K990375	DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75	Mar 09, 1999	Substantially Equivalent	Medtronic Functional Diagnostics A/S
K981004	SLE EMG ELECTRODES AND ACCESSORIES	Oct 21, 1998	Substantially Equivalent	Specialized Laboratory Equipment, Ltd.
K973529	NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES	Nov 20, 1997	Substantially Equivalent	Medicotest A/S
K973444	TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES	Nov 20, 1997	Substantially Equivalent	Medelec, Inc. D.B.A. Teca Corp.
K973442	TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES	Nov 20, 1997	Substantially Equivalent	Medelec, Inc. D.B.A. Teca Corp.
K961013	DISPOSABLE NEEDLE ELECTRODE	Dec 20, 1996	Substantially Equivalent	Medelec Intl. Corp.
K960591	RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP	Jun 13, 1996	Substantially Equivalent	Chalgren Enterprises, Inc.
K955335	DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE	Jan 29, 1996	Substantially Equivalent	Chalgren Enterprises, Inc.
K932691	PROTECTRODE SYSTEMS CONCENTRIC	Nov 16, 1995	Substantially Equivalent	The Electrode Store, Inc.
K953887	RE-USABLE CONCENTRIC NEEDLE	Oct 31, 1995	Substantially Equivalent	Chalgren Enterprises, Inc.
K953886	RE-USABLE MONOPOLAR NEEDLE	Oct 31, 1995	Substantially Equivalent	Chalgren Enterprises, Inc.
K932059	NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE	Oct 04, 1994	Substantially Equivalent	Dantec Medical, Inc.
K931029	DISPOSABLE CONCENTRIC NEEDLE ELECTRODE	Aug 25, 1994	Substantially Equivalent	Chalgren Enterprises, Inc.
K931966	DANTEC DISPOSABLE CONCENTRIC NEEDLE	Mar 30, 1994	Substantially Equivalent	Dantec Medical, Inc.
K924521	DISPOSABLE CONCENTRIC NEEDLE ELECTRODE	Feb 12, 1993	Substantially Equivalent	Chalgren Enterprises, Inc.
K912283	DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE	Mar 16, 1992	Substantially Equivalent	Chalgren Enterprises, Inc.
K912282	DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS	Mar 16, 1992	Substantially Equivalent	Chalgren Enterprises, Inc.
K896874	DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12	Jun 18, 1990	Substantially Equivalent	Dantec Medical, Inc.
K895460	CONCENTRIC ELECTRODE TYPE #13R01, 13R02	Jun 18, 1990	Substantially Equivalent	Dantec Electronics, Inc.
K870795	EMG ELECTRODES AND EXTENSION CORDS	Mar 13, 1987	Substantially Equivalent	Nihon Kohden America, Inc.
K854664	MEB-5200	Aug 14, 1986	Substantially Equivalent	Nihon Kohden America, Inc.