510(k) · Cleared
ClearedSuperior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GXY Electrode, Cutaneous
Cleared on Sep 3, 2010 as substantially equivalent to K083350 (Covidien LP, 2009) and 1 other predicate after a 199-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it.
- Decided
- Sep 3, 2010
- Review
- 199 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902195 (1990). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK902195 TBD Tens Reusable ElectrodeEmpi · 1990 · Recalled
- This deviceK100418 Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating…Covidien · 2010
- Descendant · cites it directly · 3 of its ownK182111 DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK241512 Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd · 2025
- Descendant · 3 generations on · 0 of its ownK253237 Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm…Elde Medikal Sanayi ve Ticaret Anonim Sirketi · 2026
- Descendant · 2 generations on · 0 of its ownK183154 SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited · 2019
Most influential descendants
Showing 4 of 4 · See all- K182111DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019 · cites it directly3descendants
- K241512Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd · 2025 · 2 generations on1descendant
- K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi · 2026 · 3 generations on0descendants
- K183154SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902195 | TBD Tens Reusable Electrode | Empi | 1990 | 1 |
| 0 (this device) | K100418 | Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode | Covidien | 2010 | — |
| +1 | K182111 | DL Self-adhesive Electrode | Shaoxing DL Healthcare Co., Ltd. | 2019 | — |
| +2 | K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | 2025 | — |
| +3 | K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 2026 | — |
| +2 | K183154 | SM Electrodes | Hong Qiangxing (Shenzhen) Electronics Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 GXY? 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 GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K083350 | Tens/Nmes/Fes Stimulating ElectrodeSummary page 2…ical technological characteristics as compared to the predicate prescription Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode (K083350). The electrode is composed of a cover, reinforcement film, lead wire, glue, silver print, conductive member, conductive h… | 2009 |
| * | K902195 | TBD Tens Reusable ElectrodeSummary page 1…lass HI 3. Predicate Devices: * Superior Starburst Reusable Self-Adhering TENSINMESIFES Stimulating Electrode (K(083350) * TENS Reusable Electrode (K(902195) 4. Device Description: The Superior Starburst Reusable Self-Adhering TENSINMESIFES Stimulating Electrode is a… | 1990 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182111 | DL Self-adhesive Electrode | 2019 | 3 |
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?
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, 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 | 7 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
The Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is indicated for use with transcutaneous electrical stimulation devices to provide the conductive interface between the stimulation device and the patient's skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100418: Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100418
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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