510(k) · Cleared
ClearedElectrode Needles
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 May 27, 1999 as substantially equivalent to K981004 (Specialized Laboratory Equipment, Ltd., 1998) and 13 other predicates after a 143-day review. Its family tree reaches back 2 generations to 1987. 55 later devices descend from it.
- Decided
- May 27, 1999
- Review
- 143 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 2 generations to K870795 (1987). 17 ancestors in all, the oldest K850107 (1985). 55 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK870795 Emg Electrodes and Extension CordsNihon Kohden America, Inc. · 1987
- 1 generation backK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
- This deviceK990015 Electrode NeedlesTechnomed Europe · 1999
- Descendant · cites it directly · 50 of its ownK022914 Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002
- Descendant · 2 generations on · 35 of its ownK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- Descendant · 3 generations on · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- Descendant · 4 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- Descendant · 5 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K022914Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002 · cites it directly50descendants
- K112718Nuvasive NVM5 SystemNuvasive, Inc. · 2012 · 2 generations on35descendants
- K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · 3 generations on33descendants
- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 4 generations on24descendants
- K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 5 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K870795 | Emg Electrodes and Extension Cords | Nihon Kohden America, Inc. | 1987 | — |
| −1 | K981004 | Sle Emg Electrodes and Accessories | Specialized Laboratory Equipment, Ltd. | 1998 | — |
| 0 (this device) | K990015 | Electrode Needles | Technomed Europe | 1999 | — |
| +1 | K022914 | Rhythmlink International Subdermal Needle Electrodes | Rhythmlink International, LLC | 2002 | — |
| +2 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| +3 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| +4 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| +5 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (14)
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 |
|---|---|---|---|
| * | K981004 | Sle Emg Electrodes and AccessoriesSummary page 1…trode EEG / EMG F) Proprietary name: Technomed EEG / EMG needle electrodes G) Classification number: 89 IKT H) Substantial Equivalence: SLE Electrodes and accessories K981004 Neuroline disposable concentric needle electrode K973529 Electrode Needle diagnostic EMG K961013 Re-useable Bipolar Concentric ne… | 1998 |
| * | K973529 | Neuroline, Disposable Concentric Needle ElectrodesSummary page 1…needle electrodes G) Classification number: 89 IKT H) Substantial Equivalence: SLE Electrodes and accessories K981004 Neuroline disposable concentric needle electrode K973529 Electrode Needle diagnostic EMG K961013 Re-useable Bipolar Concentric needle K960591 Disposable hypodermic monopolar needle recor… | 1997 |
| * | K961013 | Disposable Needle ElectrodeSummary page 1…ber: 89 IKT H) Substantial Equivalence: SLE Electrodes and accessories K981004 Neuroline disposable concentric needle electrode K973529 Electrode Needle diagnostic EMG K961013 Re-useable Bipolar Concentric needle K960591 Disposable hypodermic monopolar needle recording K955335 Re-useable Concentric Needl… | 1996 |
| * | K960591 | RE-Usable Bipolar Concentric Needle (237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STPSummary page 1…Electrodes and accessories K981004 Neuroline disposable concentric needle electrode K973529 Electrode Needle diagnostic EMG K961013 Re-useable Bipolar Concentric needle K960591 Disposable hypodermic monopolar needle recording K955335 Re-useable Concentric Needle electrode K953887 Reusable monopolar Needle… | 1996 |
| * | K955335 | Disposable Hypodermic Monopolar Needle Recording ElectrodeSummary page 1…concentric needle electrode K973529 Electrode Needle diagnostic EMG K961013 Re-useable Bipolar Concentric needle K960591 Disposable hypodermic monopolar needle recording K955335 Re-useable Concentric Needle electrode K953887 Reusable monopolar Needle K953886 Monopolar EMG needle electrode, K933806 EEG Need… | 1996 |
| * | K953887 | RE-Usable Concentric NeedleSummary page 1…eedle diagnostic EMG K961013 Re-useable Bipolar Concentric needle K960591 Disposable hypodermic monopolar needle recording K955335 Re-useable Concentric Needle electrode K953887 Reusable monopolar Needle K953886 Monopolar EMG needle electrode, K933806 EEG Needle Electrode, K933796 Electrode Needle diagnost… | 1995 |
| * | K953886 | RE-Usable Monopolar NeedleSummary page 1…eable Bipolar Concentric needle K960591 Disposable hypodermic monopolar needle recording K955335 Re-useable Concentric Needle electrode K953887 Reusable monopolar Needle K953886 Monopolar EMG needle electrode, K933806 EEG Needle Electrode, K933796 Electrode Needle diagnostic EMG K912283 Detachable Disposab… | 1995 |
| * | K933806 | Monopolar Emg Needle ElectrodeSummary page 1…Disposable hypodermic monopolar needle recording K955335 Re-useable Concentric Needle electrode K953887 Reusable monopolar Needle K953886 Monopolar EMG needle electrode, K933806 EEG Needle Electrode, K933796 Electrode Needle diagnostic EMG K912283 Detachable Disposable monopolar Needle Electrode K912283 Di… | 1994 |
| * | K933796 | Eeg Needle ElectrodeSummary page 1…r needle recording K955335 Re-useable Concentric Needle electrode K953887 Reusable monopolar Needle K953886 Monopolar EMG needle electrode, K933806 EEG Needle Electrode, K933796 Electrode Needle diagnostic EMG K912283 Detachable Disposable monopolar Needle Electrode K912283 Disposable Monopolar Needle elec… | 1994 |
| * | K912283 | Detachable, Disposable Monopolar Needle ElectrodeSummary page 1…ncentric Needle electrode K953887 Reusable monopolar Needle K953886 Monopolar EMG needle electrode, K933806 EEG Needle Electrode, K933796 Electrode Needle diagnostic EMG K912283 Detachable Disposable monopolar Needle Electrode K912283 Disposable Monopolar Needle electrode , various models K912282 Disposabl… | 1992 |
| * | K912282 | Disposable Monopolar Needle Electrode, Var ModelsSummary page 1…lectrode, K933796 Electrode Needle diagnostic EMG K912283 Detachable Disposable monopolar Needle Electrode K912283 Disposable Monopolar Needle electrode , various models K912282 Disposable EEG Needle Electrodes, K901280 Monopolar needle electrode K900098 Concentric Needle electrodes various sizes K850107… | 1992 |
| * | K901280 | Disposible Eeg Needle ElectrodesSummary page 1…tic EMG K912283 Detachable Disposable monopolar Needle Electrode K912283 Disposable Monopolar Needle electrode , various models K912282 Disposable EEG Needle Electrodes, K901280 Monopolar needle electrode K900098 Concentric Needle electrodes various sizes K850107 and,...and... many more I) Device descrip… | 1990 |
| * | K900098 | Monopolar Needle ElectrodeSummary page 1…le monopolar Needle Electrode K912283 Disposable Monopolar Needle electrode , various models K912282 Disposable EEG Needle Electrodes, K901280 Monopolar needle electrode K900098 Concentric Needle electrodes various sizes K850107 and,...and... many more I) Device description: Technomed Europe Needle elect… | 1990 |
| * | K850107 | Concentric Needle Electrodes-Various Sizes W/ConneSummary page 1…nopolar Needle electrode , various models K912282 Disposable EEG Needle Electrodes, K901280 Monopolar needle electrode K900098 Concentric Needle electrodes various sizes K850107 and,...and... many more I) Device description: Technomed Europe Needle electrode’s and accessories consist of a variety of need… | 1985 |
What descends from it? (55)
See all 555 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022914 | Rhythmlink International Subdermal Needle Electrodes | 2002 | 50 |
| K050194 | Axon Systems Subdermal Needle Electrodes | 2005 | 13 |
| K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal… | 2013 | 3 |
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable… | 2026 | 0 |
| K040639 | Isurg Disposable Subdermal Needle Electrode | 2004 | 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K022914 (Rhythmlink International, LLC, 2002) has gone furthest, with 50 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 | — |
What is it indicated for?
Technomed Europe diagnostic needie electrodes are intended to be inserted in the subdermal, muscle or nerve tissue to sense bio-electric, EMG or EEG, signals distally, and are intended to be proximal be connected to electromyography / electroencephalogram recording equipment.
The intended use of the Technomed devices are consistent with Code of Federal Regulations title 21,volume 8 part 882.1350.
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/K990015 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990015: Electrode Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990015
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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