Atlas FDA

IKT

43 FDA 510(k) clearances · Product code

140 daysmedian time to decision
343 days90th percentile
43clearances measured

FDA profile

Official device name
Electrode, Needle, Diagnostic Electromyograph
Device class
Class II (moderate risk)
Regulation
21 CFR 890.1385
Medical specialty
Physical Medicine
Flags
Third-party review eligible
Adverse events (MAUDE)
2011: 7 · 2012: 7 · 2013: 12 · 2014: 9 · 2018: 25 · 2019: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
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) (K253581)Technomed Europe2026-03-15
Allergan Botox Needle Electrode (K173815)Natus Manufacturing Limited2018-06-29
Myoject Luer Lock Needle Electrode (K161430)Natus Manufacturing Limited2017-03-02
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes (K152984)Bio Protech, Inc.2016-06-03
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 Limited2015-08-28
EMG RECORDING ELECTRODE ASSEMBLY (K120342)Rhythmlink International, LLC2012-06-22
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES (K112034)Carefusion 209, Inc.2011-08-12
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES (K111131)Carefusion 209, Inc.2011-06-17
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE (K092973)Bionen S.A.S.2010-10-07
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE (K093825)Ambu A/S2010-01-13
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, (K091410)Spes Medica Srl2009-08-11
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R (K091055)Rhythmlink International, LLC2009-06-23
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R (K091056)Rhythmlink International, LLC2009-06-23
ULTRASHARP CONCENTRIC NEEDLES (K080914)Rochester Electro Medical, Inc.2008-07-15
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE (K071186)Ambu A/S2007-07-30
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED (K062437)Technomed Europe2007-02-16
NEUROLINE, SUBDERMAL NEEDLE ELECTRODES (K020907)Medicotest A/S2002-06-14
STERILE EMG ELECTRODES (K011818)Nicolet Biomedical, Inc.2001-09-06
DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 (K002992)Medtronic Functional Diagnostics A/S2001-08-15
DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE (K001869)Medicotest A/S2000-09-18
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 (K982950)Chalgren Enterprises, Inc.1999-06-22
ELECTRODE NEEDLES (K990015)Technomed Europe1999-05-27
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 (K990375)Medtronic Functional Diagnostics A/S1999-03-09
SLE EMG ELECTRODES AND ACCESSORIES (K981004)Specialized Laboratory Equipment, Ltd.1998-10-21
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES (K973529)Medicotest A/S1997-11-20
TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES (K973444)Medelec, Inc. D.B.A. Teca Corp.1997-11-20
TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES (K973442)Medelec, Inc. D.B.A. Teca Corp.1997-11-20
DISPOSABLE NEEDLE ELECTRODE (K961013)Medelec Intl. Corp.1996-12-20
RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP (K960591)Chalgren Enterprises, Inc.1996-06-13
DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE (K955335)Chalgren Enterprises, Inc.1996-01-29
PROTECTRODE SYSTEMS CONCENTRIC (K932691)The Electrode Store, Inc.1995-11-16
RE-USABLE MONOPOLAR NEEDLE (K953886)Chalgren Enterprises, Inc.1995-10-31
RE-USABLE CONCENTRIC NEEDLE (K953887)Chalgren Enterprises, Inc.1995-10-31
NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE (K932059)Dantec Medical, Inc.1994-10-04
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE (K931029)Chalgren Enterprises, Inc.1994-08-25
DANTEC DISPOSABLE CONCENTRIC NEEDLE (K931966)Dantec Medical, Inc.1994-03-30
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE (K924521)Chalgren Enterprises, Inc.1993-02-12
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS (K912282)Chalgren Enterprises, Inc.1992-03-16
DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE (K912283)Chalgren Enterprises, Inc.1992-03-16
DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12 (K896874)Dantec Medical, Inc.1990-06-18
CONCENTRIC ELECTRODE TYPE #13R01, 13R02 (K895460)Dantec Electronics, Inc.1990-06-18
EMG ELECTRODES AND EXTENSION CORDS (K870795)Nihon Kohden America, Inc.1987-03-13
MEB-5200 (K854664)Nihon Kohden America, Inc.1986-08-14

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