510(k) · Cleared
ClearedConductive Eeg Electrolyte
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumedics USA, Ltd. · GYB Media, Electroconductive
Cleared on Dec 17, 2003 as substantially equivalent to K022006 (The Dezac Group, 2002) and 1 other predicate after a 79-day review. Its family tree reaches back 2 generations to 1998. 9 later devices descend from it.
- Decided
- Dec 17, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983964 (1998). 3 ancestors in all, the oldest K883149 (1988). 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK983964 Batch #6060 Conductive GelSkylark Device Co., Ltd. · 1998
- 1 generation backK022006 Conductive GelThe Dezac Group · 2002
- This deviceK033052 Conductive Eeg ElectrolyteCompumedics USA, Ltd. · 2003
- Descendant · cites it directly · 8 of its ownK111717 Electro-GelElectro-Cap Intl., Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK190050 Tech Dots - Adhesive and conductive gelSpes Medica Srl · 2019
- Descendant · 3 generations on · 2 of its ownK192606 SAC2 - Electrode CreamSpes Medica Srl · 2020
- Descendant · 2 generations on · 2 of its ownK161715 EndyGelEndymed Medical, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK200402 DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd. · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K111717Electro-GelElectro-Cap Intl., Inc. · 2012 · cites it directly8descendants
- K190050Tech Dots - Adhesive and conductive gelSpes Medica Srl · 2019 · 2 generations on6descendants
- K192606SAC2 - Electrode CreamSpes Medica Srl · 2020 · 3 generations on2descendants
- K161715EndyGelEndymed Medical, Ltd. · 2017 · 2 generations on2descendants
- K200402DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983964 | Batch #6060 Conductive Gel | Skylark Device Co., Ltd. | 1998 | — |
| −1 | K022006 | Conductive Gel | The Dezac Group | 2002 | — |
| 0 (this device) | K033052 | Conductive Eeg Electrolyte | Compumedics USA, Ltd. | 2003 | — |
| +1 | K111717 | Electro-Gel | Electro-Cap Intl., Inc. | 2012 | — |
| +2 | K190050 | Tech Dots - Adhesive and conductive gel | Spes Medica Srl | 2019 | — |
| +3 | K192606 | SAC2 - Electrode Cream | Spes Medica Srl | 2020 | — |
| +2 | K161715 | EndyGel | Endymed Medical, Ltd. | 2017 | — |
| +2 | K200402 | DR-HO'S Electro Therapy Conductive Gel | Guangzhou Xinbo Electronic Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 1…uikGel® Classification Name: Electroconductivye Media Predicate Devices: Conductive Gel K022006 TEN20 Conductive K883 149 Description of… | 2002 |
| * | K883149 | TEN20 ConductiveSummary page 1…Conductive Gel K022006 TEN20 Conductive K883 149 Description of the Device: A jellylike mass consisting of salts combined with carbohydrate thickening agent, h… | 1988 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111717 | Electro-Gel | 2012 | 8 |
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 5 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K111717 (Electro-Cap Intl., Inc., 2012) has gone furthest, with 8 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.
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 Quik gel is intended to enhance electrical conductivity by facilitating transmission of the electrophysiological signals from the patient to the equipment to reduce impedance at the electrode-to-skin interface. It also helps the Quik cap electrodes adhere to the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033052: Conductive Eeg Electrolyte.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033052
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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