510(k) · Cleared
ClearedDisposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spes Medica Srl · IKT Electrode, Needle, Diagnostic Electromyograph
Cleared on Aug 11, 2009 as substantially equivalent to K973529 (Medicotest A/S, 1997) and 9 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Aug 11, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 2 generations to K973444 (1997). 11 ancestors in all, the oldest K931966 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK973444 Teca Myoject Disposable Needle ElectrodesMedelec, Inc. D.B.A. Teca Corp. · 1997
- 1 generation backK062437 Disposable Hypodermic Emg Needle Electrode Technomed Europe Version…Technomed Europe · 2007
- This deviceK091410 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 ownK152984 Disposable Concentric Needle electrodes, Disposable Monopolar Needle…Bio Protech, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973444 | Teca Myoject Disposable Needle Electrodes | Medelec, Inc. D.B.A. Teca Corp. | 1997 | — |
| −1 | K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and… | Technomed Europe | 2007 | — |
| 0 (this device) | 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 | K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle… | Bio Protech, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 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? (10)
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 |
|---|---|---|---|
| * | K973529 | Neuroline, Disposable Concentric Needle ElectrodesSummary page 1…ntric Needle Electrodes, Neuroline, Disposable Monopolar Needle Electrodes, Diagnostic Electromyography Needle Electrode, Disposable Hypodermic Needle, K973529, K983597, K001869 - AMBU A/S: Neuroline Concentric Needle Electrode, Neuroline, Disposable Monopolar Needle Elect… | 1997 |
| * | K983597 | Neuroline, Disposable Monopolar Needle ElectrodesSummary page 1…dle Electrodes, Neuroline, Disposable Monopolar Needle Electrodes, Diagnostic Electromyography Needle Electrode, Disposable Hypodermic Needle, K973529, K983597, K001869 - AMBU A/S: Neuroline Concentric Needle Electrode, Neuroline, Disposable Monopolar Needle Electrode, K07… | 1999 |
| * | K001869 | Diagnostic Electromyography Needle Electrode, Disposable Hypodermic NeedleSummary page 1…rodes, Neuroline, Disposable Monopolar Needle Electrodes, Diagnostic Electromyography Needle Electrode, Disposable Hypodermic Needle, K973529, K983597, K001869 - AMBU A/S: Neuroline Concentric Needle Electrode, Neuroline, Disposable Monopolar Needle Electrode, K071186, K07… | 2000 |
| * | K071186 | Modification to: Ambu Neuroline Concentric Needle ElectrodeSummary page 1…posable Hypodermic Needle, K973529, K983597, K001869 - AMBU A/S: Neuroline Concentric Needle Electrode, Neuroline, Disposable Monopolar Needle Electrode, K071186, K071185 - MEDELEC: Disposable Needle Electrode, Teca Disposable Monopolar Needle Electrodes, Teca Myoject Dispos… | 2007 |
| * | K071185 | Modification to: Ambu Neuroline, Disposable Monopolar Needle ElectrodeSummary page 1…ypodermic Needle, K973529, K983597, K001869 - AMBU A/S: Neuroline Concentric Needle Electrode, Neuroline, Disposable Monopolar Needle Electrode, K071186, K071185 - MEDELEC: Disposable Needle Electrode, Teca Disposable Monopolar Needle Electrodes, Teca Myoject Disposable Need… | 2007 |
| * | K961013 | Disposable Needle ElectrodeSummary page 1…lectrode, K071186, K071185 - MEDELEC: Disposable Needle Electrode, Teca Disposable Monopolar Needle Electrodes, Teca Myoject Disposable Needle Electrodes K961013, K973442, K973444 - DANTEC MEDICAL, INC.: Dantec Disposable Concentric Needle, K931966 - TECHNOMED EUROPE: Disl5osa… | 1996 |
| * | K973442 | Teca Disposable Monopolar Needle ElectrodesSummary page 1…K071186, K071185 - MEDELEC: Disposable Needle Electrode, Teca Disposable Monopolar Needle Electrodes, Teca Myoject Disposable Needle Electrodes K961013, K973442, K973444 - DANTEC MEDICAL, INC.: Dantec Disposable Concentric Needle, K931966 - TECHNOMED EUROPE: Disl5osable Hypod… | 1997 |
| * | K973444 | Teca Myoject Disposable Needle ElectrodesSummary page 1…K071185 - MEDELEC: Disposable Needle Electrode, Teca Disposable Monopolar Needle Electrodes, Teca Myoject Disposable Needle Electrodes K961013, K973442, K973444 - DANTEC MEDICAL, INC.: Dantec Disposable Concentric Needle, K931966 - TECHNOMED EUROPE: Disl5osable Hypodermic EMG… | 1997 |
| * | K931966 | Dantec Disposable Concentric NeedleSummary page 1…polar Needle Electrodes, Teca Myoject Disposable Needle Electrodes K961013, K973442, K973444 - DANTEC MEDICAL, INC.: Dantec Disposable Concentric Needle, K931966 - TECHNOMED EUROPE: Disl5osable Hypodermic EMG Needle Electrode K062437 DESCRIPTION OF THE DEVICE A diagn… | 1994 |
| * | K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledSummary page 1…1013, K973442, K973444 - DANTEC MEDICAL, INC.: Dantec Disposable Concentric Needle, K931966 - TECHNOMED EUROPE: Disl5osable Hypodermic EMG Needle Electrode K062437 DESCRIPTION OF THE DEVICE A diagnostic electromyography needle electrode is a monopolar or bipolar needle intend… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092973 | Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle | 2010 | 1 |
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 12 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K092973 (Bionen S.A.S., 2010) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K973529.
How does its category compare?
All IKT devicesIKT Electrode, Needle, Diagnostic Electromyograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
The disposable hypodermic needle is inteded to be used for injection of the Botulinum Toxin into a muscle, while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091410 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091410: Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091410
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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