Product code IKT— Physical Medicine
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
- Classification name
- Electrode, Needle, Diagnostic Electromyograph
- Device class
- Class 2
- Regulation
- 21 CFR 890.1385
- Advisory panel
- Physical Medicine
- Total cleared
- 43
- First cleared
- Most recent
Market context for product code IKT
FDA has cleared devices under product code IKT between 1986 and 2026, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2018
- 2017
- 2016
- 2015
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2002
- 2001
- 2000
- 1999
Top applicants under product code IKT
Recent clearances under product code IKT
- K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001) +5 more
- K173815 — Allergan Botox Needle Electrode
- K161430 — Myoject Luer Lock Needle Electrode
- K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
- 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
- K120342 — EMG RECORDING ELECTRODE ASSEMBLY
- K112034 — TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
- K111131 — TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
- K092973 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
- K093825 — AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
- K091410 — DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
- K091055 — RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
- K091056 — RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
- K080914 — ULTRASHARP CONCENTRIC NEEDLES
- K071186 — MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
- K062437 — DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
- K020907 — NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
- K011818 — STERILE EMG ELECTRODES
- K002992 — DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
- K001869 — DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
- K982950 — FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
- K990015 — ELECTRODE NEEDLES
- K990375 — DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
- K981004 — SLE EMG ELECTRODES AND ACCESSORIES
- K973442 — TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
- K973444 — TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES
- K973529 — NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
- K961013 — DISPOSABLE NEEDLE ELECTRODE
- K960591 — RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP
- K955335 — DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
- K932691 — PROTECTRODE SYSTEMS CONCENTRIC
- K953886 — RE-USABLE MONOPOLAR NEEDLE
- K953887 — RE-USABLE CONCENTRIC NEEDLE
- K932059 — NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE
- K931029 — DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
- K931966 — DANTEC DISPOSABLE CONCENTRIC NEEDLE
- K924521 — DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
- K912282 — DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS
- K912283 — DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
- K895460 — CONCENTRIC ELECTRODE TYPE #13R01, 13R02
- K896874 — DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12
- K870795 — EMG ELECTRODES AND EXTENSION CORDS
- K854664 — MEB-5200
Data sourced from openFDA. This site is unofficial and independent of the FDA.