510(k) · Cleared

Cleared

Sterile Emg Electrodes

K011818510(k) AbbreviatedCleared Sep 6, 200187-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

Nicolet Biomedical, Inc. · IKT Electrode, Needle, Diagnostic Electromyograph

Cleared on Sep 6, 2001 as substantially equivalent to K850107 (Nicolet Biomedical Instruments, 1985) and 5 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided: Sep 6, 2001
Review: 87 days
Class: Class II
Product code: IKT
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K850107 (1985). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK850107 Concentric Needle Electrodes-Various Sizes W/ConneNicolet Biomedical Instruments · 1985
This deviceK011818 Sterile Emg ElectrodesNicolet Biomedical, Inc. · 2001
Descendant · cites it directly · 0 of its ownK111131 Teca (TM) Elite Disposable Monopolar NeedlesCarefusion 209, Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all

K111131Teca (TM) Elite Disposable Monopolar NeedlesCarefusion 209, Inc. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K850107	Concentric Needle Electrodes-Various Sizes W/Conne	Nicolet Biomedical Instruments	1985	—
0 (this device)	K011818	Sterile Emg Electrodes	Nicolet Biomedical, Inc.	2001	—
+1	K111131	Teca (TM) Elite Disposable Monopolar Needles	Carefusion 209, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	2	0
1993	1	0
1996	1	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K011818, 1985–2011Source: 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? (6)

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
*	K850107	Concentric Needle Electrodes-Various Sizes W/Conne Summary page 1 …anufacture: Trade Name: Product Code: Classification: 510(k) Number: Manufacture: Trade Name: Product Code: Classification: 21 CFR 890.1385, EMG Needle Electrode K850107 Nicolet Biomedical Incorporated Concentric EMG Electrodes (non-sterile) IKT 21 890.1385, Diagnostic Electromyograph Needle El…	Nicolet Biomedical Instruments	1985	—
*	K912282	Disposable Monopolar Needle Electrode, Var Models Summary page 1 …, EMG Needle Electrode K850107 Nicolet Biomedical Incorporated Concentric EMG Electrodes (non-sterile) IKT 21 890.1385, Diagnostic Electromyograph Needle Electrode K912282, K924521, K955335, K982950 Chalgren, Incorporated Disposable Monopolar EMG Electrode, Disposable Concentric Needle Electrode, D…	Chalgren Enterprises, Inc.	1992	—
*	K924521	Disposable Concentric Needle Electrode Summary page 1 …dle Electrode K850107 Nicolet Biomedical Incorporated Concentric EMG Electrodes (non-sterile) IKT 21 890.1385, Diagnostic Electromyograph Needle Electrode K912282, K924521, K955335, K982950 Chalgren, Incorporated Disposable Monopolar EMG Electrode, Disposable Concentric Needle Electrode, Disposable…	Chalgren Enterprises, Inc.	1993	—
*	K955335	Disposable Hypodermic Monopolar Needle Recording Electrode Summary page 1 …rode K850107 Nicolet Biomedical Incorporated Concentric EMG Electrodes (non-sterile) IKT 21 890.1385, Diagnostic Electromyograph Needle Electrode K912282, K924521, K955335, K982950 Chalgren, Incorporated Disposable Monopolar EMG Electrode, Disposable Concentric Needle Electrode, Disposable Hypoderm…	Chalgren Enterprises, Inc.	1996	—
*	K982950	Fine Wire Electrode Mmodel Numbers 221-14-730, 221-24-730, 221-14-550, 221-24-550 Summary page 1 …0107 Nicolet Biomedical Incorporated Concentric EMG Electrodes (non-sterile) IKT 21 890.1385, Diagnostic Electromyograph Needle Electrode K912282, K924521, K955335, K982950 Chalgren, Incorporated Disposable Monopolar EMG Electrode, Disposable Concentric Needle Electrode, Disposable Hypodermic Monopo…	Chalgren Enterprises, Inc.	1999	—
*	K912783	Disposable Monopolar Needle Electrode Summary page 1 …sable Concentric Needle Electrode, Disposable Hypodermic Monopolar Needle, Fine Wire Electrode (Hook Wire) IKT 21 890.1385, Diagnostic Electromyograph Needle Electrode K912783 Class A Incorporated Disposable Monopolar Needle Electrode GXZ 21 882.1350, Needle Electrode Nicolet Biomedical hic. 5225 Ve…	Class A Ent.	1992	—

Also cleared against K850107: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K111131	Teca (TM) Elite Disposable Monopolar Needles	Carefusion 209, Inc.	2011	0

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 6 ancestors has a recall.
Of its descendants, K111131 (Carefusion 209, Inc., 2011) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K850107.

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?

Concentric, Monopolar, Hook Wire and Hypodermic EMG Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.

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/K011818 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011818: Sterile Emg Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011818

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026