510(k) · Cleared
ClearedDisposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Functional Diagnostics A/S · IKT Electrode, Needle, Diagnostic Electromyograph
Cleared on Aug 15, 2001 after a 324-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Aug 15, 2001
- Review
- 324 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK002992 Disposable Hypodermic Needle Electrode, Model…Medtronic Functional Diagnostics A/S · 2001
- Descendant · cites it directly · 6 of its ownK062437 Disposable Hypodermic Emg Needle Electrode Technomed Europe Version…Technomed Europe · 2007
- Descendant · 2 generations on · 3 of its ownK130136 Disposable and Reusable Concentric Needle Electrodes,Disposable and…Technomed Europe · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK091410 Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl · 2009
- Descendant · 2 generations on · 1 of its ownK092973 Disposable and Reusable Concentric Needles / Disposable and Reusable…Bionen S.A.S. · 2010
- Descendant · 3 generations on · 0 of its ownK241045 Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K062437Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledTechnomed Europe · 2007 · cites it directly6descendants
- K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe · 2013 · 2 generations on3descendants
- K091410Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl · 2009 · 2 generations on2descendants
- K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleBionen S.A.S. · 2010 · 2 generations on1descendant
- K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002992 | Disposable Hypodermic Needle Electrode, Model… | Medtronic Functional Diagnostics A/S | 2001 | — |
| +1 | K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and… | Technomed Europe | 2007 | — |
| +2 | K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable… | Technomed Europe | 2013 | 2 |
| +2 | K091410 | Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, | Spes Medica Srl | 2009 | — |
| +2 | K092973 | Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar… | Bionen S.A.S. | 2010 | — |
| +3 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2024 | 1 | 0 |
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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 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?
- Of its descendants, K062437 (Technomed Europe, 2007) has gone furthest, with 6 descendants of its own.
How does its category compare?
All IKT devicesIKT Electrode, Needle, Diagnostic Electromyograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K002992 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002992: Disposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002992
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026