510(k) · Cleared
ClearedDisposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technomed Europe · IKT Electrode, Needle, Diagnostic Electromyograph
Cleared on Feb 16, 2007 as substantially equivalent to K973444 (Medelec, Inc. D.B.A. Teca Corp., 1997) and 1 other predicate after a 189-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.
- Decided
- Feb 16, 2007
- Review
- 189 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973444 (1997). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK973444 Teca Myoject Disposable Needle ElectrodesMedelec, Inc. D.B.A. Teca Corp. · 1997
- This deviceK062437 Disposable Hypodermic Emg Needle Electrode Technomed Europe Version…Technomed Europe · 2007
- Descendant · cites it directly · 3 of its ownK130136 Disposable and Reusable Concentric Needle Electrodes,Disposable and…Technomed Europe · 2013 · Recalled
- Descendant · cites it directly · 2 of its ownK091410 Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl · 2009
- Descendant · cites it directly · 1 of its ownK092973 Disposable and Reusable Concentric Needles / Disposable and Reusable…Bionen S.A.S. · 2010
- Descendant · 2 generations on · 0 of its ownK241045 Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
- Descendant · 2 generations on · 0 of its ownK161566 DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe · 2013 · cites it directly3descendants
- K091410Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl · 2009 · cites it directly2descendants
- K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleBionen S.A.S. · 2010 · cites it directly1descendant
- K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024 · 2 generations on0descendants
- K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973444 | Teca Myoject Disposable Needle Electrodes | Medelec, Inc. D.B.A. Teca Corp. | 1997 | — |
| 0 (this device) | K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and… | Technomed Europe | 2007 | — |
| +1 | K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable… | Technomed Europe | 2013 | 2 |
| +1 | K091410 | Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, | Spes Medica Srl | 2009 | — |
| +1 | K092973 | Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar… | Bionen S.A.S. | 2010 | — |
| +2 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | 2024 | — |
| +2 | K161566 | DMS Disposable Subdermal Needle Electrodes | Daehan Medical Systems Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2024 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K973444 | Teca Myoject Disposable Needle ElectrodesSummary page 1…needle electrode Classification Name: Diagnostic electromyography needle electrode (21 CFR section 890.1385) Substantial Equivalence: K973444: Teca Myoject disposable needle electrode K002992: Medtronic Disposable Hypodermic Needle… | 1997 |
| * | K002992 | Disposable Hypodermic Needle Electrode, Model…Summary page 1…electrode (21 CFR section 890.1385) Substantial Equivalence: K973444: Teca Myoject disposable needle electrode K002992: Medtronic Disposable Hypodermic Needle Electrode Device description: The dis… | 2001 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All IKT devicesIKT Electrode, Needle, Diagnostic Electromyograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IKT
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · IKT
71in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IKT
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IKT
3in 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?
The disposable hypodermic EMG needle electrode is used for muscle stimulation, motor unit action potential recording and drug delivery.
The motQr nerves are monitored by detecting EMG activity in the muscles they innervate.
The drug used should be Botox Botilium Toxin type A.
Note: Technomed Europe does not supply any drugs with the Disposable hypodermic EMG needle electrodes nor does Technomed Europe offer for sale any form of drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062437: Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062437
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