510(k) · Cleared
Recalled · Class II · 2012TBD Tens Reusable Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empi · GXY Electrode, Cutaneous
Cleared on Jun 8, 1990 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 8, 1990
- Review
- 23 days
- Class
- Class II
- Product code
- GXY
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK902195 TBD Tens Reusable ElectrodeEmpi · 1990
- Descendant · cites it directly · 4 of its ownK100418 Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating…Covidien · 2010
- Descendant · 2 generations on · 3 of its ownK182111 DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK241512 Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd · 2025
- Descendant · 4 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 · 3 generations on · 0 of its ownK183154 SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited · 2019
Most influential descendants
Showing 5 of 5 · See all- K100418Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating ElectrodeCovidien · 2010 · cites it directly4descendants
- K182111DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019 · 2 generations on3descendants
- K241512Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd · 2025 · 3 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 · 4 generations on0descendants
- K183154SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902195 | TBD Tens Reusable Electrode | Empi | 1990 | — |
| +1 | K100418 | Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode | Covidien | 2010 | — |
| +2 | K182111 | DL Self-adhesive Electrode | Shaoxing DL Healthcare Co., Ltd. | 2019 | — |
| +3 | K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | 2025 | — |
| +4 | K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 2026 | — |
| +3 | K183154 | SM Electrodes | Hong Qiangxing (Shenzhen) Electronics Limited | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2019 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100418 | Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode | 2010 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 9, 2012 | Class II | Z-0501-2013 | Employee error | Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100418 (Covidien, 2010) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K902195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902195: TBD Tens Reusable Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902195
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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