510(k) Report

510(k) · Cleared

Cleared

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)

K253581510(k) TraditionalCleared Mar 15, 2026118-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

Technomed Europe · IKT Electrode, Needle, Diagnostic Electromyograph

Cleared on Mar 15, 2026 as substantially equivalent to K990015 (Technomed Europe, 1999) after a 118-day review. Its family tree reaches back 3 generations to 1987.

Decided
Mar 15, 2026
Review
118 days
Class
Class II
Product code
IKT
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K870795 (1987). 18 ancestors in all, the oldest K850107 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 3 other ancestors1995: 2 other ancestors1994: 4 other ancestors1992: 2 other ancestors1990: 2 other ancestors1985: 1 other ancestorReference device: K062437 · Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled · Technomed Europe · 2007Reference device: K130136 · Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes, · Technomed Europe · 2013 · recalledK870795 · Emg Electrodes and Extension Cords · Nihon Kohden America, Inc. · 1987K981004 · Sle Emg Electrodes and Accessories · Specialized Laboratory Equipment, Ltd. · 1998K990015 · Electrode Needles · Technomed Europe · 19991990200020102020
Other ancestors, by generation 2 generations back: 13 other ancestors3 generations back: 2 other ancestors K990015 · Electrode Needles · Technomed Europe · 1999K981004 · Sle Emg Electrodes and Accessories · Specialized Laboratory Equipment, Ltd. · 1998K870795 · Emg Electrodes and Extension Cords · Nihon Kohden America, Inc. · 19870
  1. Root · 3 generations backK870795 Emg Electrodes and Extension CordsNihon Kohden America, Inc. · 1987
  2. 2 generations backK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
  3. 1 generation backK990015 Electrode NeedlesTechnomed Europe · 1999
  4. This deviceK253581 Disposable Concentric Needle Electrode 0.30x25mm Red…Technomed Europe · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K870795Emg Electrodes and Extension CordsNihon Kohden America, Inc.1987—
−2K981004Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd.1998—
−1K990015Electrode NeedlesTechnomed Europe1999—
0 (this device)K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001)…Technomed Europe2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199020
199220
199440
199520
199630
199710
FIG. 1 — Lineage of K253581, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K990015Electrode Needles
Summary page 5
…Needle Regulation Number 890.1385 Product Code(s) IKT, GXZ C. Legally Marketed Predicate Devices Primary Predicate Device: Technomed EEG / EMG needle electrodes (K990015) Product Code: 21 CFR § 882.1350 GXZ…
Technomed Europe1999—
†K062437Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledTechnomed Europe2007—
†K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe20132

Also cleared against K990015: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 39 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
  • 1 of the 18 ancestors has a recall of any class.
  • 4 other devices also cite its predicate K990015.

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. 2026, this device’s year, is highlighted.

FDA decisions per year · IKT

1in 2018

2007: 22008: 12009: 32010: 22011: 22012: 12015: 12016: 12017: 12018: 12026 (partial year): 1
2007high 3 (2009) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IKT

71in 2009

2009: 71 days median
2007high 71 (2009)2026

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

Recalls per year · IKT

1in 2007

2007: 1
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

2008: 22009: 72010: 52011: 72012: 72013: 122014: 92015: 52016: 72017: 82018: 252019: 152020: 32021: 52022: 42023: 82024: 92025: 3
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—10
20081—02
200937107
20102—05
20112—07
20121—07
20130—012
20140—09
20151—05
20161—07
20171—08
20181—025
20190—015
20200—03
20210—05
20220—04
20230—08
20240—09
20250—03
20261—0—

What is it indicated for?

Disposable Concentric Needle Electrodes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyography (EMG) and nerve potential signal.

Indications for use as stated in the FDA summary.

Also cleared against K990015

4 other devices cite the same predicate.

  • K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,Technomed Europe · 20132 recalls
  • K050194Axon Systems Subdermal Needle ElectrodesAxon Systems, Inc. · 2005
  • K040639Isurg Disposable Subdermal Needle ElectrodeIsurgical · 2004
  • K022914Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002

More from Technomed Europe

13 FDA decisions under this applicant name. See the company

  • K254183MR Conditional Cup ElectrodesTechnomed Europe · 2026
  • K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
  • K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,Technomed Europe · 20132 recalls
  • K121257Laryngeal ElectrodeTechnomed Europe · 2012
  • K110422Surgical StimulatorsTechnomed Europe · 20111 recall

Recent decisions in IKT

The IKT category page

  • K173815Allergan Botox Needle ElectrodeNatus Manufacturing Limited · 2018
  • K161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing Limited · 2017
  • K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle…Bio Protech, Inc. · 2016
  • K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle…Natus Manufacturing Limited · 2015
  • K120342Emg Recording Electrode AssemblyRhythmlink International, LLC · 2012

https://510kreport.com/device/K253581 · printed Nov 6, 2026

Cite this page

510(k) Report. “K253581: 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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253581

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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