510(k) · Cleared
ClearedMailuokang Self-adhesive Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mailuokang Technology Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Mar 8, 2016 as substantially equivalent to K112312 (Phoenix Medical Devices, Llp, 2012) after a 162-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Mar 8, 2016
- Review
- 162 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945676 (1995). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 5 generations backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
- 4 generations backK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
- 3 generations backK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
- 2 generations backK083302 Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009
- 1 generation backK112312 TheratrodePhoenix Medical Devices, Llp · 2012
- This deviceK152815 Mailuokang Self-adhesive ElectrodeShenzhen Mailuokang Technology Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK181234 Self-adhesive ElectrodeDong Guan OU Kang Electronics Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K181234Self-adhesive ElectrodeDong Guan OU Kang Electronics Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945676 | Guardian Disposable Tens and Tens/Nmes Electrodes | Selectivemed Components, Inc. | 1995 | — |
| −5 | K050469 | EZ-Stik Electrodes | Naimco, Inc. | 2005 | 4 |
| −4 | K052875 | Prostim Reusable Neurostimulation Electrodes | Summit Manufacturing, LLC | 2005 | — |
| −3 | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and… | Gemore Technology Co, Ltd. | 2007 | — |
| −2 | K083302 | Lifecare Electrodes | Everyway Medical Instruments Co.,Ltd | 2009 | — |
| −1 | K112312 | Theratrode | Phoenix Medical Devices, Llp | 2012 | — |
| 0 (this device) | K152815 | Mailuokang Self-adhesive Electrode | Shenzhen Mailuokang Technology Co., Ltd. | 2016 | — |
| +1 | K181234 | Self-adhesive Electrode | Dong Guan OU Kang Electronics Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K112312 | TheratrodeSummary page 5…on Number: 882.1320 Predicate Device Information Sponsor: Phoenix Medical Devices, LLC Device: THERATRODE 510(K) Number: K112312 Device Description Mailuokang Self-adhesive Electrode is used as a reusable and re-positionable transcutaneous electrical nerve… | 2012 |
| † | K970246 | Edta Cavit | 1997 |
| † | K090198 | Jiajian Self-Adhesive Electrode | 2009 |
| † | K142055 | Gymform Abs & Core | 2015 |
| † | K020735 | Sof-Pach Reusable Neurostimulation Electrodes | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181234 | Self-adhesive Electrode | 2018 | 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 21 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K181234 (Dong Guan OU Kang Electronics Co., Ltd., 2018) has gone furthest, with 0 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. 2016, 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?
Mailuokang Self-adhesive Electrode is intended for use as reusable, conductive adhesive interface between the patient’s skin and the electrical stimulation devices. Example electrical stimulation devices for current applications of the electrodes includes, but are not limited to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152815: Mailuokang Self-adhesive Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152815
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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