FDA Product Code IKT: Electrode, Needle, Diagnostic Electromyograph
Leading manufacturers include Chalgren Enterprises, Inc., Technomed Europe and Rhythmlink International, LLC.
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
Cleared
Mar 15, 2026
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001)
Technomed Europe
Neurology
118d
Cleared
Jun 29, 2018
Allergan Botox Needle Electrode
Natus Manufacturing Limited
Neurology
196d
Cleared
Mar 02, 2017
Myoject Luer Lock Needle Electrode
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
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
Natus Manufacturing Limited
Neurology
270d
Cleared
Jun 22, 2012
EMG RECORDING ELECTRODE ASSEMBLY
Rhythmlink International, LLC
Neurology
140d
Cleared
Aug 12, 2011
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
Carefusion 209, Inc.
Neurology
28d
Cleared
Jun 17, 2011
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
Carefusion 209, Inc.
Neurology
57d
Cleared
Jan 13, 2010
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
Ambu A/S
Neurology
30d
Cleared
Jun 23, 2009
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
Rhythmlink International, LLC
Neurology
71d
Cleared
Jun 23, 2009
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
Rhythmlink International, LLC
Neurology
71d
Cleared
Jul 30, 2007
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
Ambu A/S
Neurology
91d
Cleared
Feb 16, 2007
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
Technomed Europe
Neurology
189d
Cleared
Jun 22, 1999
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
Chalgren Enterprises, Inc.
Neurology
305d
Cleared
May 27, 1999
ELECTRODE NEEDLES
Technomed Europe
Neurology
143d
Cleared
Mar 09, 1999
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25
Medtronic Functional Diagnostics A/S
Neurology
29d
Cleared
Oct 21, 1998
SLE EMG ELECTRODES AND ACCESSORIES
Specialized Laboratory Equipment, Ltd.
Neurology
217d
Cleared
Nov 20, 1997
TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
Medelec, Inc. D.B.A. Teca Corp.
Neurology
70d
Cleared
Nov 20, 1997
TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES
Medelec, Inc. D.B.A. Teca Corp.
Neurology
70d
Cleared
Nov 20, 1997
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
Medicotest A/S
Neurology
63d
Cleared
Dec 20, 1996
DISPOSABLE NEEDLE ELECTRODE
Medelec Intl. Corp.
Neurology
282d
Cleared
Jun 13, 1996
RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP
Chalgren Enterprises, Inc.
Neurology
122d
Cleared
Jan 29, 1996
DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
Chalgren Enterprises, Inc.
Neurology
70d
Cleared
Oct 31, 1995
RE-USABLE MONOPOLAR NEEDLE
Chalgren Enterprises, Inc.
Neurology
75d
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 →