510(k) · Cleared
ClearedDisposable Monoplar Meddle Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dantec Medical, Inc. · GXE Leukotome
Cleared on Dec 8, 1992 after a 354-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Dec 8, 1992
- Review
- 354 days
- Class
- Class I
- Product code
- GXE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK915741 Disposable Monoplar Meddle ElectrodesDantec Medical, Inc. · 1992
- Descendant · cites it directly · 6 of its ownK990375 Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN…Medtronic Functional Diagnostics A/S · 1999
- Descendant · 2 generations on · 5 of its ownK072276 Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd. · 2008
- Descendant · 3 generations on · 3 of its ownK130136 Disposable and Reusable Concentric Needle Electrodes,Disposable and…Technomed Europe · 2013 · Recalled
- Descendant · 4 generations on · 0 of its ownK241045 Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
- Descendant · 3 generations on · 0 of its ownK232581 Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K990375Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75Medtronic Functional Diagnostics A/S · 1999 · cites it directly6descendants
- K072276Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd. · 2008 · 2 generations on5descendants
- K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe · 2013 · 3 generations on3descendants
- K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024 · 4 generations on0descendants
- K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915741 | Disposable Monoplar Meddle Electrodes | Dantec Medical, Inc. | 1992 | — |
| +1 | K990375 | Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50… | Medtronic Functional Diagnostics A/S | 1999 | — |
| +2 | K072276 | Subdermal Needle Electrodes | Xian Friendship Electronics Co., Ltd. | 2008 | — |
| +3 | K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable… | Technomed Europe | 2013 | 2 |
| +4 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | 2024 | — |
| +3 | K232581 | Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2023 | 1 | 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 GXE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990375 | Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 | 1999 | 6 |
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, K990375 (Medtronic Functional Diagnostics A/S, 1999) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GXE devicesGXE Leukotome: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXE
FDA has decided no GXE device since 2007.
Median 510(k) review, days · GXE
Too few GXE 510(k)s in any year since 2007 to give a median.
Recalls per year · GXE
No recall names GXE since 2007.
Adverse event reports per year · GXE
No MAUDE report names GXE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K915741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K915741: Disposable Monoplar Meddle Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915741
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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