510(k) · Cleared
ClearedTENS Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cathay Manufacturing Corp. · GXY Electrode, Cutaneous
Cleared on Oct 19, 2016 as substantially equivalent to K080276 (Cathay Health Care Equipment Manufacturing, Inc., 2008) and 1 other predicate after a 278-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.
- Decided
- Oct 19, 2016
- Review
- 278 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K903402 (1990). 8 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 3 generations backK963125 M and R Reusable Electrodes (Multiple)M & R Mfg., Inc. · 1997
- 2 generations backK020735 Sof-Pach Reusable Neurostimulation ElectrodesCathay International, Ltd. · 2002
- 1 generation backK080276 Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc. · 2008
- This deviceK160081 TENS ElectrodesCathay Manufacturing Corp. · 2016
- Descendant · cites it directly · 0 of its ownK210448 Adhesive ElectrodeShaoxing Yingtuo Healthcare Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK180773 Reusable and Self-Adhesive ElectrodesShaoxing Dongzhi Electrical Technology Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK171722 Electrodes with snap / Electrodes with pigtailShenzhen Konmed Technology Co., Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See all- K210448Adhesive ElectrodeShaoxing Yingtuo Healthcare Co., Ltd. · 2021 · cites it directly0descendants
- K180773Reusable and Self-Adhesive ElectrodesShaoxing Dongzhi Electrical Technology Co., Ltd. · 2018 · cites it directly0descendants
- K171722Electrodes with snap / Electrodes with pigtailShenzhen Konmed Technology Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903402 | Geohesive (TM), Model Numbers 1022L, 1023L, 1026L | Medi-Source, Inc. | 1990 | — |
| −3 | K963125 | M and R Reusable Electrodes (Multiple) | M & R Mfg., Inc. | 1997 | — |
| −2 | K020735 | Sof-Pach Reusable Neurostimulation Electrodes | Cathay International, Ltd. | 2002 | — |
| −1 | K080276 | Self-Adhesive Electrodes | Cathay Health Care Equipment Manufacturing, Inc. | 2008 | — |
| 0 (this device) | K160081 | TENS Electrodes | Cathay Manufacturing Corp. | 2016 | — |
| +1 | K210448 | Adhesive Electrode | Shaoxing Yingtuo Healthcare Co., Ltd. | 2021 | — |
| +1 | K180773 | Reusable and Self-Adhesive Electrodes | Shaoxing Dongzhi Electrical Technology Co., Ltd. | 2018 | — |
| +1 | K171722 | Electrodes with snap / Electrodes with pigtail | Shenzhen Konmed Technology Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K080276 | Self-Adhesive ElectrodesSummary page 4…any Product 510(k) Code Number SELF-ADHESIVE CATHAY Healthcare GXY K080276 ELECTRODES Equipment Manufacturing Inc. A Reference Device Chosen: Top-Rank Adhesive T… | 2008 |
| * | K132588 | Adhesive ElectrodesSummary page 4…276 ELECTRODES Equipment Manufacturing Inc. A Reference Device Chosen: Top-Rank Adhesive Top-Rank Health Care Co., GXY K132588 Electrodes Ltd Page: 1 / 6… | 2013 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K210448 (Shaoxing Yingtuo Healthcare Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080276.
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?
The proposed device is intended for use as the disposable, conductive adhesive interface between the patient’s skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
It’s for OTC use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160081 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160081: TENS Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160081
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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