510(k) · Cleared
ClearedBatch #6060 Conductive Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skylark Device Co., Ltd. · GYB Media, Electroconductive
Cleared on Dec 9, 1998 after a 33-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Dec 9, 1998
- Review
- 33 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK983964 Batch #6060 Conductive GelSkylark Device Co., Ltd. · 1998
- Descendant · cites it directly · 10 of its ownK022006 Conductive GelThe Dezac Group · 2002
- Descendant · 2 generations on · 9 of its ownK033052 Conductive Eeg ElectrolyteCompumedics USA, Ltd. · 2003
- Descendant · 3 generations on · 8 of its ownK111717 Electro-GelElectro-Cap Intl., Inc. · 2012
- Descendant · 4 generations on · 6 of its ownK190050 Tech Dots - Adhesive and conductive gelSpes Medica Srl · 2019
- Descendant · 5 generations on · 2 of its ownK192606 SAC2 - Electrode CreamSpes Medica Srl · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K022006Conductive GelThe Dezac Group · 2002 · cites it directly10descendants
- K033052Conductive Eeg ElectrolyteCompumedics USA, Ltd. · 2003 · 2 generations on9descendants
- K111717Electro-GelElectro-Cap Intl., Inc. · 2012 · 3 generations on8descendants
- K190050Tech Dots - Adhesive and conductive gelSpes Medica Srl · 2019 · 4 generations on6descendants
- K192606SAC2 - Electrode CreamSpes Medica Srl · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983964 | Batch #6060 Conductive Gel | Skylark Device Co., Ltd. | 1998 | — |
| +1 | K022006 | Conductive Gel | The Dezac Group | 2002 | — |
| +2 | K033052 | Conductive Eeg Electrolyte | Compumedics USA, Ltd. | 2003 | — |
| +3 | K111717 | Electro-Gel | Electro-Cap Intl., Inc. | 2012 | — |
| +4 | K190050 | Tech Dots - Adhesive and conductive gel | Spes Medica Srl | 2019 | — |
| +5 | K192606 | SAC2 - Electrode Cream | Spes Medica Srl | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022006 | Conductive Gel | 2002 | 10 |
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?
- Of its descendants, K022006 (The Dezac Group, 2002) has gone furthest, with 10 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?
FOR USE WITH TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS) AND EMS (ELECTRICAL MUSCLE STIMULATORS). CONDUCTIVE GEL IS USED WITH EXTERNAL ELECTRODES TO REDUCE THE IMPEDACE OF THE CONTACT BETWEEN THE ELECTRODE SURFACE AND THE SKIN.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983964 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983964: Batch #6060 Conductive Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983964
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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