510(k) · Cleared
ClearedHivox Self Adhesive Electrode Gel Pads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hivox Biotek, Inc. · GXY Electrode, Cutaneous
Cleared on Jul 25, 2014 as substantially equivalent to K070612 (Top-Rank Health Care Equipment Co., Ltd., 2007) and 2 other predicates after a 408-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Jul 25, 2014
- Review
- 408 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K070612 (2007). 3 ancestors in all, the oldest K000947 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070612 | Top-Rank Adhesive Electrode | Top-Rank Health Care Equipment Co., Ltd. | 2007 | — |
| −1 | K132588 | Adhesive Electrodes | Top-Rank Health Care Equipment Co., Ltd. | 2013 | — |
| 0 (this device) | K131720 | Hivox Self Adhesive Electrode Gel Pads | Hivox Biotek, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K070612 | Top-Rank Adhesive ElectrodeSummary page 1…skin and the electrical stimulator. The device is a gel pad for use with an electrode and not an electrode itself. Predicated 1) K070612, Top-Rank Adhesive Electrodes Devices: Top-Rank Health Care Equipment Co., Ltd. 2) K13258… | 2007 |
| * | K132588 | Adhesive Electrodes Cleared while this submission was under review Summary page 1…rode itself. Predicated 1) K070612, Top-Rank Adhesive Electrodes Devices: Top-Rank Health Care Equipment Co., Ltd. 2) K132588, Top-Rank Adhesive Electrodes TFop-Rank Health Care Equipment Co., Ltd. 3) K0009… | 2013 |
| * | K000947 | Ultrastim Electrode, Model US4040Summary page 1…t Co., Ltd. 2) K132588, Top-Rank Adhesive Electrodes TFop-Rank Health Care Equipment Co., Ltd. 3) K000947, Ultrastim Electrode Axelgaard Mfg. Co., Ltd. Device Description: HI1VOX self-adhesive electrode… | 2000 |
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 7 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K070612.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
HIVOX self-adhesive electrode gel pads are intended for use as disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The device is a gel pad for use with an electrode and not an electrode itself
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131720: Hivox Self Adhesive Electrode Gel Pads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131720
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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