510(k) · Cleared
ClearedDR-HO'S Electro Therapy Conductive Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Xinbo Electronic Co., Ltd. · GYB Media, Electroconductive
Cleared on Nov 25, 2020 as substantially equivalent to K022006 (The Dezac Group, 2002) and 3 other predicates after a 280-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- Nov 25, 2020
- Review
- 280 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K983964 (1998). 9 ancestors in all, the oldest K780045 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK983964 Batch #6060 Conductive GelSkylark Device Co., Ltd. · 1998
- 4 generations backK022006 Conductive GelThe Dezac Group · 2002
- 3 generations backK033052 Conductive Eeg ElectrolyteCompumedics USA, Ltd. · 2003
- 2 generations backK111717 Electro-GelElectro-Cap Intl., Inc. · 2012
- 1 generation backK161715 EndyGelEndymed Medical, Ltd. · 2017
- This deviceK200402 DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK222770 Conductive GelTop-Rank Health Care Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222770Conductive GelTop-Rank Health Care Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983964 | Batch #6060 Conductive Gel | Skylark Device Co., Ltd. | 1998 | — |
| −4 | K022006 | Conductive Gel | The Dezac Group | 2002 | — |
| −3 | K033052 | Conductive Eeg Electrolyte | Compumedics USA, Ltd. | 2003 | — |
| −2 | K111717 | Electro-Gel | Electro-Cap Intl., Inc. | 2012 | — |
| −1 | K161715 | EndyGel | Endymed Medical, Ltd. | 2017 | — |
| 0 (this device) | K200402 | DR-HO'S Electro Therapy Conductive Gel | Guangzhou Xinbo Electronic Co., Ltd. | 2020 | — |
| +1 | K222770 | Conductive Gel | Top-Rank Health Care Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 GYB? 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 GYB device
- #1 K243749 Jmoon Conductive Gelscore 10.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K022006 | Conductive GelSummary page 5…EndyMed Medical Ltd. Spes Medica S.r.l. Device Name Conductive Gel EndyGelTM Tech Dots 510(k) Number K022006 K161715 K190050 Product Code GYB GYB… | 2002 |
| * | K161715 | EndyGelSummary page 5…Spes Medica S.r.l. Device Name Conductive Gel EndyGelTM Tech Dots 510(k) Number K022006 K161715 K190050 Product Code GYB GYB GYB Regulation Nu… | 2017 |
| * | K190050 | Tech Dots - Adhesive and conductive gelSummary page 5…Device Name Conductive Gel EndyGelTM Tech Dots 510(k) Number K022006 K161715 K190050 Product Code GYB GYB GYB Regulation Number 882.1275… | 2019 |
| * | K111717 | Electro-GelSummary page 8…Conductive gel Model: DHGEL 510(k) Number Applying K022006 K161715 K190050 K111717 -- Product Code GYB GYB GYB GYB… | 2012 |
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 |
|---|---|---|---|
| K222770 | Conductive Gel | 2022 | 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 22 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K222770 (Top-Rank Health Care Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K022006.
How does its category compare?
All GYB devicesGYB Media, Electroconductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GYB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GYB
101in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GYB
1in 2021
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GYB
2in 2025
MAUDE reports naming product code GYB, 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 | 0 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 3 | 198 | 0 | 2 |
| 2021 | 2 | — | 1 (1) | 4 |
| 2022 | 3 | 101 | 0 | 4 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DR-HO'S Electro Therapy Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200402: DR-HO'S Electro Therapy Conductive Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200402
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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