Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

IKT — Predicate Candidate Screening

43 FDA 510(k) clearances under this product code; the 50 most recent screened below.

140 daysmedian FDA review time

343 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253581	Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50	Technomed Europe	2026-03-15	118	0
K173815	Allergan Botox Needle Electrode	Natus Manufacturing Limited	2018-06-29	196	0
K161430	Myoject Luer Lock Needle Electrode	Natus Manufacturing Limited	2017-03-02	283	0
K152984	Disposable Concentric Needle electrodes, Disposable Monopola	Bio Protech, Inc.	2016-06-03	238	0
K143433	Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dan	Natus Manufacturing Limited	2015-08-28	270	0
K120342	EMG RECORDING ELECTRODE ASSEMBLY	Rhythmlink International, LLC	2012-06-22	140	0
K112034	TECA ELITE DISPOSABLE CONCENTRIC NEEDLES	Carefusion 209, Inc.	2011-08-12	28	0
K111131	TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES	Carefusion 209, Inc.	2011-06-17	57	0
K092973	DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND	Bionen S.A.S.	2010-10-07	377	0
K093825	AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE	Ambu A/S	2010-01-13	30	0
K091410	DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT	Spes Medica Srl	2009-08-11	90	0
K091055	RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D03903225	Rhythmlink International, LLC	2009-06-23	71	0
K091056	RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN260322	Rhythmlink International, LLC	2009-06-23	71	0
K080914	ULTRASHARP CONCENTRIC NEEDLES	Rochester Electro Medical, Inc.	2008-07-15	105	0
K071186	MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE	Ambu A/S	2007-07-30	91	0
K062437	DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE	Technomed Europe	2007-02-16	189	0
K020907	NEUROLINE, SUBDERMAL NEEDLE ELECTRODES	Medicotest A/S	2002-06-14	86	0
K011818	STERILE EMG ELECTRODES	Nicolet Biomedical, Inc.	2001-09-06	87	0
K002992	DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013	Medtronic Functional Diagnostics A/S	2001-08-15	324	0
K001869	DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYP	Medicotest A/S	2000-09-18	90	0
K982950	FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 2	Chalgren Enterprises, Inc.	1999-06-22	305	0
K990015	ELECTRODE NEEDLES	Technomed Europe	1999-05-27	143	0
K990375	DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 3	Medtronic Functional Diagnostics A/S	1999-03-09	29	0
K981004	SLE EMG ELECTRODES AND ACCESSORIES	Specialized Laboratory Equipment, Ltd.	1998-10-21	217	0
K973529	NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES	Medicotest A/S	1997-11-20	63	0
K973444	TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES	Medelec, Inc. D.B.A. Teca Corp.	1997-11-20	70	0
K973442	TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES	Medelec, Inc. D.B.A. Teca Corp.	1997-11-20	70	0
K961013	DISPOSABLE NEEDLE ELECTRODE	Medelec Intl. Corp.	1996-12-20	282	0
K960591	RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP	Chalgren Enterprises, Inc.	1996-06-13	122	0
K955335	DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE	Chalgren Enterprises, Inc.	1996-01-29	70	0
K932691	PROTECTRODE SYSTEMS CONCENTRIC	The Electrode Store, Inc.	1995-11-16	897	0
K953886	RE-USABLE MONOPOLAR NEEDLE	Chalgren Enterprises, Inc.	1995-10-31	75	0
K953887	RE-USABLE CONCENTRIC NEEDLE	Chalgren Enterprises, Inc.	1995-10-31	75	0
K932059	NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE	Dantec Medical, Inc.	1994-10-04	523	0
K931029	DISPOSABLE CONCENTRIC NEEDLE ELECTRODE	Chalgren Enterprises, Inc.	1994-08-25	542	0
K931966	DANTEC DISPOSABLE CONCENTRIC NEEDLE	Dantec Medical, Inc.	1994-03-30	343	0
K924521	DISPOSABLE CONCENTRIC NEEDLE ELECTRODE	Chalgren Enterprises, Inc.	1993-02-12	157	0
K912282	DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS	Chalgren Enterprises, Inc.	1992-03-16	293	0
K912283	DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE	Chalgren Enterprises, Inc.	1992-03-16	298	1
K896874	DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12	Dantec Medical, Inc.	1990-06-18	192	0
K895460	CONCENTRIC ELECTRODE TYPE #13R01, 13R02	Dantec Electronics, Inc.	1990-06-18	285	0
K870795	EMG ELECTRODES AND EXTENSION CORDS	Nihon Kohden America, Inc.	1987-03-13	15	0
K854664	MEB-5200	Nihon Kohden America, Inc.	1986-08-14	267	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda