IKT · Class II · 21 CFR 890.1385

FDA Product Code IKT: Electrode, Needle, Diagnostic Electromyograph

Leading manufacturers include Chalgren Enterprises, Inc., Rhythmlink International, LLC and Natus Manufacturing Limited.

43
Total
43
Cleared
192d
Avg days
1986
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 118d recently vs 194d historically

FDA 510(k) Cleared Electrode, Needle, Diagnostic Electromyograph Devices (Product Code IKT)

43 devices
1–24 of 43
Cleared Mar 15, 2026
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001)
K253581
Technomed Europe
Neurology · 118d
Cleared Jun 29, 2018
Allergan Botox Needle Electrode
K173815
Natus Manufacturing Limited
Neurology · 196d
Cleared Mar 02, 2017
Myoject Luer Lock Needle Electrode
K161430
Natus Manufacturing Limited
Neurology · 283d
Cleared Jun 03, 2016
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
K152984
Bio Protech, Inc.
Neurology · 238d
Cleared Aug 28, 2015
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
K143433
Natus Manufacturing Limited
Neurology · 270d
Cleared Jun 22, 2012
EMG RECORDING ELECTRODE ASSEMBLY
K120342
Rhythmlink International, LLC
Neurology · 140d
Cleared Aug 12, 2011
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
K112034
Carefusion 209, Inc.
Neurology · 28d
Cleared Jun 17, 2011
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
K111131
Carefusion 209, Inc.
Neurology · 57d
Cleared Oct 07, 2010
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
K092973
Bionen S.A.S.
Neurology · 377d
Cleared Jan 13, 2010
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
K093825
Ambu A/S
Neurology · 30d
Cleared Aug 11, 2009
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
K091410
Spes Medica Srl
Neurology · 90d
Cleared Jun 23, 2009
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
K091055
Rhythmlink International, LLC
Neurology · 71d
Cleared Jun 23, 2009
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
K091056
Rhythmlink International, LLC
Neurology · 71d
Cleared Jul 15, 2008
ULTRASHARP CONCENTRIC NEEDLES
K080914
Rochester Electro Medical, Inc.
Neurology · 105d
Cleared Jul 30, 2007
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
K071186
Ambu A/S
Neurology · 91d
Cleared Feb 16, 2007
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
K062437
Technomed Europe
Neurology · 189d
Cleared Jun 14, 2002
NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
K020907
Medicotest A/S
Neurology · 86d
Cleared Sep 06, 2001
STERILE EMG ELECTRODES
K011818
Nicolet Biomedical, Inc.
Neurology · 87d
Cleared Aug 15, 2001
DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
K002992
Medtronic Functional Diagnostics A/S
Neurology · 324d
Cleared Sep 18, 2000
DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
K001869
Medicotest A/S
Neurology · 90d
Cleared Jun 22, 1999
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
K982950
Chalgren Enterprises, Inc.
Neurology · 305d
Cleared May 27, 1999
ELECTRODE NEEDLES
K990015
Technomed Europe
Neurology · 143d
Cleared Mar 09, 1999
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25
K990375
Medtronic Functional Diagnostics A/S
Neurology · 29d
Cleared Oct 21, 1998
SLE EMG ELECTRODES AND ACCESSORIES
K981004
Specialized Laboratory Equipment, Ltd.
Neurology · 217d

About Product Code IKT - Regulatory Context

510(k) Submission Activity

43 total 510(k) submissions under product code IKT since 1986, with 43 receiving FDA clearance (average review time: 192 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - IKT Product Code

Recent submissions under IKT have taken an average of 118 days to reach a decision - down from 194 days historically, suggesting improved FDA processing for this classification.

IKT devices are reviewed by the Neurology panel. Browse all Neurology devices →