510(k) · Cleared

Cleared

Disposable Needle Electrode

K961013510(k) TraditionalCleared Dec 20, 1996282-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

Medelec Intl. Corp. · IKT Electrode, Needle, Diagnostic Electromyograph

Cleared on Dec 20, 1996 after a 282-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 60 later devices descend from it.

Decided: Dec 20, 1996
Review: 282 days
Class: Class II
Product code: IKT
Recalls: None
Predicates: 0

60 later devices descend from it, 4 citing it directly.

This deviceK961013 Disposable Needle ElectrodeMedelec Intl. Corp. · 1996
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 60 descendants. See all descendants

Descendants cleared per year

1999high 6 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 60 · 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
0 (this device)	K961013	Disposable Needle Electrode	Medelec Intl. Corp.	1996	—
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	1	0
2004	1	0
2005	1	0
2007	1	0
2008	2	0
2009	1	0
2010	1	0
2011	2	0
2012	2	0
2013	3	0
2014	5	0
2015	3	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 K961013, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (60)

See all 60

4 later devices cite 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
K112034	Teca Elite Disposable Concentric Needles	Carefusion 209, Inc.	2011	5
K071186	Modification to: Ambu Neuroline Concentric Needle Electrode	Ambu A/S	2007	3
K091410	Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,	Spes Medica Srl	2009	2

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?

Of its descendants, K990015 (Technomed Europe, 1999) has gone furthest, with 55 descendants of its own.

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	—

https://510kreport.com/device/K961013 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961013: Disposable Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961013

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026