510(k) · Cleared
ClearedSM Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hong Qiangxing (Shenzhen) Electronics Limited · GXY Electrode, Cutaneous
Cleared on Mar 26, 2019 as substantially equivalent to K152648 (Suzhou Ennova Electronics Technology Co.,Ltd, 2016) and 1 other predicate after a 132-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Mar 26, 2019
- Review
- 132 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K945676 (1995). 25 ancestors in all, the oldest K902195 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 5 generations between
- 3 generations backK150971 Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015
- 2 generations backK152648 Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd · 2016
- 1 generation backK182111 DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019
- This deviceK183154 SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited · 2019
Show all 9 generations
- Root · 9 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 8 generations backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
- 7 generations backK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
- 6 generations backK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
- 5 generations backK083302 Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009
- 4 generations backK130987 Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013
- 3 generations backK150971 Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015
- 2 generations backK152648 Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd · 2016
- 1 generation backK182111 DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019
- This deviceK183154 SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945676 | Guardian Disposable Tens and Tens/Nmes Electrodes | Selectivemed Components, Inc. | 1995 | — |
| −8 | K050469 | EZ-Stik Electrodes | Naimco, Inc. | 2005 | 4 |
| −7 | K052875 | Prostim Reusable Neurostimulation Electrodes | Summit Manufacturing, LLC | 2005 | — |
| −6 | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and… | Gemore Technology Co, Ltd. | 2007 | — |
| −5 | K083302 | Lifecare Electrodes | Everyway Medical Instruments Co.,Ltd | 2009 | — |
| −4 | K130987 | Valutrode Neurostimlation Electrodes | Axelgaard Mfg. Co., Ltd. | 2013 | — |
| −3 | K150971 | Zekang Self-adhesive Electrode | Jiangsu Zekang Medical Technology Co., Ltd. | 2015 | — |
| −2 | K152648 | Ennova Self-adhesive Electrode | Suzhou Ennova Electronics Technology Co.,Ltd | 2016 | — |
| −1 | K182111 | DL Self-adhesive Electrode | Shaoxing DL Healthcare Co., Ltd. | 2019 | — |
| 0 (this device) | K183154 | SM Electrodes | Hong Qiangxing (Shenzhen) Electronics Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K152648 | Ennova Self-adhesive ElectrodeSummary page 5…en not in use, the hydrogel face is covered by a PET(polyethylene terephthalate) carrier line. 3. Predicate Device Identification K152648--Ennova Self-adhesive Electrode--January 12, 2016 K182111--DL Adhesive Electrode--January 17, 2019 4. Non-Clinical Test Conclusi… | 2016 |
| * | K182111 | DL Self-adhesive Electrode Cleared while this submission was under review Summary page 5…thylene terephthalate) carrier line. 3. Predicate Device Identification K152648--Ennova Self-adhesive Electrode--January 12, 2016 K182111--DL Adhesive Electrode--January 17, 2019 4. Non-Clinical Test Conclusion Bench tests were conducted on SM Electrodes to verify t… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 10 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 25 ancestors have a recall of any class.
- 1 other device also cites its predicate K152648.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
SM Electrodes are intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183154 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183154: SM Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183154
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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