510(k) · Cleared
ClearedAdhesive Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shaoxing Yingtuo Healthcare Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Aug 31, 2021 as substantially equivalent to K160081 (Cathay Manufacturing Corp., 2016) after a 196-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Aug 31, 2021
- Review
- 196 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K903402 (1990). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 4 generations backK963125 M and R Reusable Electrodes (Multiple)M & R Mfg., Inc. · 1997
- 3 generations backK020735 Sof-Pach Reusable Neurostimulation ElectrodesCathay International, Ltd. · 2002
- 2 generations backK080276 Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc. · 2008
- 1 generation backK160081 TENS ElectrodesCathay Manufacturing Corp. · 2016
- This deviceK210448 Adhesive ElectrodeShaoxing Yingtuo Healthcare Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903402 | Geohesive (TM), Model Numbers 1022L, 1023L, 1026L | Medi-Source, Inc. | 1990 | — |
| −4 | K963125 | M and R Reusable Electrodes (Multiple) | M & R Mfg., Inc. | 1997 | — |
| −3 | K020735 | Sof-Pach Reusable Neurostimulation Electrodes | Cathay International, Ltd. | 2002 | — |
| −2 | K080276 | Self-Adhesive Electrodes | Cathay Health Care Equipment Manufacturing, Inc. | 2008 | — |
| −1 | K160081 | TENS Electrodes | Cathay Manufacturing Corp. | 2016 | — |
| 0 (this device) | K210448 | Adhesive Electrode | Shaoxing Yingtuo Healthcare Co., Ltd. | 2021 | — |
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 |
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 |
|---|---|---|---|
| * | K160081 | TENS ElectrodesSummary page 4…II Predicate Device Trade name: TENS Electrodes Common name: Cutaneous Electrode Classification: Class II, 21 CFR 882.1320 Product Code: GXY Premarket Notification: K160081 Company name: CATHAY MANUFACTURING CORP. IV Device description The adhesive electrode is placed onto human skin and connected w… | 2016 |
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 31 years and passes through 6 companies; a new generation was cleared every 6.1 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K160081.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 stimulator, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210448: 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/K210448
Report an extraction error
Are you the manufacturer?
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