Panels › Physical Medicine › Product code IKT · Class 2
Electrode, Needle, Diagnostic Electromyograph
Regulation 890.1385
1510(k)s in 12 months (43 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in IKT
| Company | 510(k)s | Recalls |
|---|---|---|
| Chalgren Enterprises, Inc. | 9 | 1 |
| Technomed Europe | 3 | 1 |
| Dantec Medical, Inc. | 3 | 0 |
| Medicotest A/S | 3 | 0 |
| Natus Manufacturing Limited | 3 | 0 |
| Rhythmlink International, LLC | 3 | 0 |
| Ambu A/S | 2 | 0 |
| Carefusion 209, Inc. | 2 | 0 |
| Medelec, Inc. D.B.A. Teca Corp. | 2 | 0 |
| Medtronic Functional Diagnostics A/S | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 15, 2026 | K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Y Technomed Europe, NL | IKT |
| Jun 29, 2018 | K173815 | Allergan Botox Needle Electrode Natus Manufacturing Limited, IE | IKT |
| Mar 2, 2017 | K161430 | Myoject Luer Lock Needle Electrode Natus Manufacturing Limited, IE | IKT |
| Jun 3, 2016 | K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Dispos Bio Protech, Inc., KR | IKT |
| Aug 28, 2015 | K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec Natus Manufacturing Limited, IE | IKT |
| Jun 22, 2012 | K120342 | EMG RECORDING ELECTRODE ASSEMBLY Rhythmlink International, LLC | IKT |
| Aug 12, 2011 | K112034 | TECA ELITE DISPOSABLE CONCENTRIC NEEDLES Carefusion 209, Inc. | IKT |
| Jun 17, 2011 | K111131 | TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES Carefusion 209, Inc. | IKT |
| Oct 7, 2010 | K092973 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE Bionen S.A.S. | IKT |
| Jan 13, 2010 | K093825 | AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE Ambu A/S | IKT |
| Aug 11, 2009 | K091410 | DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, Spes Medica Srl, IT | IKT |
| Jun 23, 2009 | K091056 | RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R Rhythmlink International, LLC | IKT |
| Jun 23, 2009 | K091055 | RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R Rhythmlink International, LLC | IKT |
| Jul 15, 2008 | K080914 | ULTRASHARP CONCENTRIC NEEDLES Rochester Electro Medical, Inc. | IKT |
| Jul 30, 2007 | K071186 | MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE Ambu A/S | IKT |
| Feb 16, 2007 | K062437 | DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED Technomed Europe, NL | IKT |
| Jun 14, 2002 | K020907 | NEUROLINE, SUBDERMAL NEEDLE ELECTRODES Medicotest A/S | IKT |
| Sep 6, 2001 | K011818 | STERILE EMG ELECTRODES Nicolet Biomedical, Inc. | IKT |
| Aug 15, 2001 | K002992 | DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 Medtronic Functional Diagnostics A/S, DK | IKT |
| Sep 18, 2000 | K001869 | DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE Medicotest A/S | IKT |
| Jun 22, 1999 | K982950 | FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 Chalgren Enterprises, Inc. | IKT |
| May 27, 1999 | K990015 | ELECTRODE NEEDLES Technomed Europe, NL | IKT |
| Mar 9, 1999 | K990375 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 Medtronic Functional Diagnostics A/S, DK | IKT |
| Oct 21, 1998 | K981004 | SLE EMG ELECTRODES AND ACCESSORIES Specialized Laboratory Equipment, Ltd. | IKT |
| Nov 20, 1997 | K973529 | NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES Medicotest A/S | IKT |
| Nov 20, 1997 | K973444 | TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES Medelec, Inc. D.B.A. Teca Corp. | IKT |
| Nov 20, 1997 | K973442 | TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES Medelec, Inc. D.B.A. Teca Corp. | IKT |
| Dec 20, 1996 | K961013 | DISPOSABLE NEEDLE ELECTRODE Medelec Intl. Corp., GB | IKT |
| Jun 13, 1996 | K960591 | RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP Chalgren Enterprises, Inc. | IKT |
| Jan 29, 1996 | K955335 | DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE Chalgren Enterprises, Inc. | IKT |
| Nov 16, 1995 | K932691 | PROTECTRODE SYSTEMS CONCENTRIC The Electrode Store, Inc. | IKT |
| Oct 31, 1995 | K953887 | RE-USABLE CONCENTRIC NEEDLE Chalgren Enterprises, Inc. | IKT |
| Oct 31, 1995 | K953886 | RE-USABLE MONOPOLAR NEEDLE Chalgren Enterprises, Inc. | IKT |
| Oct 4, 1994 | K932059 | NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE Dantec Medical, Inc. | IKT |
| Aug 25, 1994 | K931029 | DISPOSABLE CONCENTRIC NEEDLE ELECTRODE Chalgren Enterprises, Inc. | IKT |
| Mar 30, 1994 | K931966 | DANTEC DISPOSABLE CONCENTRIC NEEDLE Dantec Medical, Inc. | IKT |
| Feb 12, 1993 | K924521 | DISPOSABLE CONCENTRIC NEEDLE ELECTRODE Chalgren Enterprises, Inc. | IKT |
| Mar 16, 1992 | K912283 | DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE Chalgren Enterprises, Inc. | IKT |
| Mar 16, 1992 | K912282 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS Chalgren Enterprises, Inc. | IKT |
| Jun 18, 1990 | K896874 | DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12 Dantec Medical, Inc. | IKT |
| Jun 18, 1990 | K895460 | CONCENTRIC ELECTRODE TYPE #13R01, 13R02 Dantec Electronics, Inc. | IKT |
| Mar 13, 1987 | K870795 | EMG ELECTRODES AND EXTENSION CORDS Nihon Kohden America, Inc. | IKT |
| Aug 14, 1986 | K854664 | MEB-5200 Nihon Kohden America, Inc. | IKT |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.