510(k) · Cleared

Cleared

Sle Emg Electrodes and Accessories

K981004510(k) TraditionalCleared Oct 21, 1998217-day reviewClass II21 CFR 890.1385

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Specialized Laboratory Equipment, Ltd. · IKT Electrode, Needle, Diagnostic Electromyograph

Cleared on Oct 21, 1998 as substantially equivalent to K973529 (Medicotest A/S, 1997) and 6 other predicates after a 217-day review. Its family tree reaches back 1 generation to 1987. 56 later devices descend from it.

Decided: Oct 21, 1998
Review: 217 days
Class: Class II
Product code: IKT
Recalls: None
Predicates: 7

Its longest line of descent runs back 1 generation to K870795 (1987). 7 ancestors in all. 56 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK870795 Emg Electrodes and Extension CordsNihon Kohden America, Inc. · 1987
This deviceK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
Descendant · cites it directly · 55 of its ownK990015 Electrode NeedlesTechnomed Europe · 1999
Descendant · 2 generations on · 50 of its ownK022914 Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002
Descendant · 3 generations on · 35 of its ownK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
Descendant · 4 generations on · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
Descendant · 5 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

1999high 6 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 56 · See all

K990015Electrode NeedlesTechnomed Europe · 1999 · cites it directly55descendants
K022914Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002 · 2 generations on50descendants
K112718Nuvasive NVM5 SystemNuvasive, Inc. · 2012 · 3 generations on35descendants
K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · 4 generations on33descendants
K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 5 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K870795	Emg Electrodes and Extension Cords	Nihon Kohden America, Inc.	1987	—
0 (this device)	K981004	Sle Emg Electrodes and Accessories	Specialized Laboratory Equipment, Ltd.	1998	—
+1	K990015	Electrode Needles	Technomed Europe	1999	—
+2	K022914	Rhythmlink International Subdermal Needle Electrodes	Rhythmlink International, LLC	2002	—
+3	K112718	Nuvasive NVM5 System	Nuvasive, Inc.	2012	—
+4	K123307	Nuvasive NVM5 System	Nuvasive, Inc.	2013	—
+5	K132694	Nuvasive NVM5 System	Nu Vasive, Incorporated	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1994	2	0
1995	2	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	1	0
2004	1	0
2005	1	0
2008	2	0
2010	1	0
2011	1	0
2012	2	0
2013	3	0
2014	5	0
2015	2	0
2016	3	0
2017	4	0
2018	3	0
2019	6	0
2020	1	0
2021	2	0
2022	2	0
2023	5	0
2024	3	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K981004, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IKT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IKT device

#1 K253581 Disposable Concentric Needle Electrode…score 11.6 · 3 generations · no Class I recall

Get a 510(k) Report

What was it cleared against? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K973529	Neuroline, Disposable Concentric Needle Electrodes Summary page 1 …rietary Name: SLE EMG Electrodes and Accessories Classification Number: 89IKT Substantial Equivalence: Neuroline Disposable Concentric Needle Electrode, Medicotest A/S (K973529), Re-usable Concentric Needle, Chalgren Ent., Inc. (K953887), Re-usable Monopolar Needle, Chalgren Ent., Inc. (K953886), Needle E…	Medicotest A/S	1997	—
*	K953887	RE-Usable Concentric Needle Summary page 1 …ion Number: 89IKT Substantial Equivalence: Neuroline Disposable Concentric Needle Electrode, Medicotest A/S (K973529), Re-usable Concentric Needle, Chalgren Ent., Inc. (K953887), Re-usable Monopolar Needle, Chalgren Ent., Inc. (K953886), Needle Electrodes and Disposable Scalp Electrode, Dantec Medical, In…	Chalgren Enterprises, Inc.	1995	—
*	K953886	RE-Usable Monopolar Needle Summary page 1 …able Concentric Needle Electrode, Medicotest A/S (K973529), Re-usable Concentric Needle, Chalgren Ent., Inc. (K953887), Re-usable Monopolar Needle, Chalgren Ent., Inc. (K953886), Needle Electrodes and Disposable Scalp Electrode, Dantec Medical, Inc. (K932059), Dantec Disposable Concentric Needle, Dantec M…	Chalgren Enterprises, Inc.	1995	—
*	K932059	Needle Electrodes and Disposable Scalp Electrode Summary page 1 …Needle, Chalgren Ent., Inc. (K953887), Re-usable Monopolar Needle, Chalgren Ent., Inc. (K953886), Needle Electrodes and Disposable Scalp Electrode, Dantec Medical, Inc. (K932059), Dantec Disposable Concentric Needle, Dantec Medical, Inc. (K931966), Disposable Monopolar Needle Electrode, Var Models, Chalgre…	Dantec Medical, Inc.	1994	—
*	K931966	Dantec Disposable Concentric Needle Summary page 1 …algren Ent., Inc. (K953886), Needle Electrodes and Disposable Scalp Electrode, Dantec Medical, Inc. (K932059), Dantec Disposable Concentric Needle, Dantec Medical, Inc. (K931966), Disposable Monopolar Needle Electrode, Var Models, Chalgren Ent., Inc. (K912282), and EMG Electrodes and Extens…	Dantec Medical, Inc.	1994	—
*	K912282	Disposable Monopolar Needle Electrode, Var Models Summary page 1 …tec Medical, Inc. (K932059), Dantec Disposable Concentric Needle, Dantec Medical, Inc. (K931966), Disposable Monopolar Needle Electrode, Var Models, Chalgren Ent., Inc. (K912282), and EMG Electrodes and Extension Cords, Nihon Koden, Inc. (K870795), and others. F. Device Description: The SL…	Chalgren Enterprises, Inc.	1992	—
*	K870795	Emg Electrodes and Extension Cords Summary page 2 …. (K931966), Disposable Monopolar Needle Electrode, Var Models, Chalgren Ent., Inc. (K912282), and EMG Electrodes and Extension Cords, Nihon Koden, Inc. (K870795), and others. F. Device Description: The SLE EMG Electrodes and Accessories device consists of a variety of needle electrodes an…	Nihon Kohden America, Inc.	1987	—

Also cleared against K973529: 4 other devices →

What descends from it? (56)

See all 56

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K990015	Electrode Needles	Technomed Europe	1999	55

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 7 ancestors has a recall.
Of its descendants, K990015 (Technomed Europe, 1999) has gone furthest, with 55 descendants of its own.
4 other devices also cite its predicate K973529.

How does its category compare?

All IKT devices

IKT Electrode, Needle, Diagnostic Electromyograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IKT

1in 2018

2007high 3 (2009) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IKT

71in 2009

2007high 71 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IKT

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IKT

3in 2025

2007high 25 (2018) · low 0 (2007)2025

MAUDE reports naming product code IKT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	1	0
2008	1	—	0	2
2009	3	71	0	7
2010	2	—	0	5
2011	2	—	0	7
2012	1	—	0	7
2013	0	—	0	12
2014	0	—	0	9
2015	1	—	0	5
2016	1	—	0	7
2017	1	—	0	8
2018	1	—	0	25
2019	0	—	0	15
2020	0	—	0	3
2021	0	—	0	5
2022	0	—	0	4
2023	0	—	0	8
2024	0	—	0	9
2025	0	—	0	3
2026	1	—	0	—

What is it indicated for?

SLE EMG Electrodes and Accessories are intended for use in recording muscle activity for electromyography applications.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K981004 · printed Nov 5, 2026

Cite this page

510(k) Report. “K981004: Sle Emg Electrodes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981004

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026