510(k) · Cleared
ClearedConductive Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Dezac Group · GYB Media, Electroconductive
Cleared on Sep 13, 2002 as substantially equivalent to K983964 (Skylark Device Co., Ltd., 1998) after an 86-day review. Its family tree reaches back 1 generation to 1998. 10 later devices descend from it.
- Decided
- Sep 13, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983964 (1998). 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983964 Batch #6060 Conductive GelSkylark Device Co., Ltd. · 1998
- This deviceK022006 Conductive GelThe Dezac Group · 2002
- Descendant · cites it directly · 9 of its ownK033052 Conductive Eeg ElectrolyteCompumedics USA, Ltd. · 2003
- Descendant · 2 generations on · 8 of its ownK111717 Electro-GelElectro-Cap Intl., Inc. · 2012
- Descendant · 3 generations on · 6 of its ownK190050 Tech Dots - Adhesive and conductive gelSpes Medica Srl · 2019
- Descendant · 4 generations on · 2 of its ownK192606 SAC2 - Electrode CreamSpes Medica Srl · 2020
- Descendant · 3 generations on · 2 of its ownK161715 EndyGelEndymed Medical, Ltd. · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K033052Conductive Eeg ElectrolyteCompumedics USA, Ltd. · 2003 · cites it directly9descendants
- K111717Electro-GelElectro-Cap Intl., Inc. · 2012 · 2 generations on8descendants
- K190050Tech Dots - Adhesive and conductive gelSpes Medica Srl · 2019 · 3 generations on6descendants
- K192606SAC2 - Electrode CreamSpes Medica Srl · 2020 · 4 generations on2descendants
- K161715EndyGelEndymed Medical, Ltd. · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983964 | Batch #6060 Conductive Gel | Skylark Device Co., Ltd. | 1998 | — |
| 0 (this device) | K022006 | Conductive Gel | The Dezac Group | 2002 | — |
| +1 | K033052 | Conductive Eeg Electrolyte | Compumedics USA, Ltd. | 2003 | — |
| +2 | K111717 | Electro-Gel | Electro-Cap Intl., Inc. | 2012 | — |
| +3 | K190050 | Tech Dots - Adhesive and conductive gel | Spes Medica Srl | 2019 | — |
| +4 | K192606 | SAC2 - Electrode Cream | Spes Medica Srl | 2020 | — |
| +3 | K161715 | EndyGel | Endymed Medical, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 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? (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 |
|---|---|---|---|
| * | K983964 | Batch #6060 Conductive GelSummary page 2…Page 13 5 10k)Pmnarket Notification Dezac Group I Conductive Gel K983964 Skylark Device Co Ltd. 34 Chung Shan North Road 12h Floor, Sec 3… | 1998 |
What descends from it? (10)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K033052 (Compumedics USA, Ltd., 2003) has gone furthest, with 9 descendants of its own.
How does its category compare?
All GYB devicesGYB Media, Electroconductive: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve
stimulators) and EMS (electronic muscle stimulators). 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/K022006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022006: 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/K022006
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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