510(k) · Cleared
ClearedDisposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
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 Mar 9, 1999 as substantially equivalent to K915741 (Dantec Medical, Inc., 1992) after a 29-day review. Its family tree reaches back 1 generation to 1992. 6 later devices descend from it.
- Decided
- Mar 9, 1999
- Review
- 29 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915741 (1992). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK915741 Disposable Monoplar Meddle ElectrodesDantec Medical, Inc. · 1992
- This deviceK990375 Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN…Medtronic Functional Diagnostics A/S · 1999
- Descendant · cites it directly · 5 of its ownK072276 Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 3 of its ownK130136 Disposable and Reusable Concentric Needle Electrodes,Disposable and…Technomed Europe · 2013 · Recalled
- Descendant · 3 generations on · 0 of its ownK241045 Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
- Descendant · 2 generations on · 0 of its ownK232581 Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. · 2023
- Descendant · 3 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- K072276Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd. · 2008 · cites it directly5descendants
- K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe · 2013 · 2 generations on3descendants
- K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024 · 3 generations on0descendants
- K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. · 2023 · 2 generations on0descendants
- K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915741 | Disposable Monoplar Meddle Electrodes | Dantec Medical, Inc. | 1992 | — |
| 0 (this device) | K990375 | Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50… | Medtronic Functional Diagnostics A/S | 1999 | — |
| +1 | K072276 | Subdermal Needle Electrodes | Xian Friendship Electronics Co., Ltd. | 2008 | — |
| +2 | K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable… | Technomed Europe | 2013 | 2 |
| +3 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | 2024 | — |
| +2 | K232581 | Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023 | — |
| +3 | K161566 | DMS Disposable Subdermal Needle Electrodes | Daehan Medical Systems Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2023 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K915741 | Disposable Monoplar Meddle ElectrodesSummary page 1…reviously marketed 13 R Series Disposable Monopolar Needles electrodes, which were previously determined by FDA to be substantially equivalent the 8" of December, 1992, K915741. 1(4) COMPANY CONFIDENTIAL Medtronic Functional Diagnostics A/S Tonsbakken 16-18 Tel: +45 44 57 90 00 DK-2740 SKOVLUNDE Fax: + 45… | 1992 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072276 | Subdermal Needle Electrodes | 2008 | 5 |
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?
- Its one ancestor has no recall.
- Of its descendants, K072276 (Xian Friendship Electronics Co., Ltd., 2008) has gone furthest, with 5 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?
The Disposable Monopolar Needles Electrodes are used for recording unit potentials in skeletal muscles, spontaneous activity, interference patterns and conduction velocity studies.
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/K990375 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990375: Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990375
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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