510(k) · Cleared
ClearedTech Dots - Adhesive and conductive gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spes Medica Srl · GYB Media, Electroconductive
Cleared on Jul 19, 2019 as substantially equivalent to K111717 (Electro-Cap Intl., Inc., 2012) after a 190-day review. Its family tree reaches back 4 generations to 1998. 6 later devices descend from it.
- Decided
- Jul 19, 2019
- Review
- 190 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983964 (1998). 7 ancestors in all, the oldest K780045 (1978). 6 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK983964 Batch #6060 Conductive GelSkylark Device Co., Ltd. · 1998
- 3 generations backK022006 Conductive GelThe Dezac Group · 2002
- 2 generations backK033052 Conductive Eeg ElectrolyteCompumedics USA, Ltd. · 2003
- 1 generation backK111717 Electro-GelElectro-Cap Intl., Inc. · 2012
- This deviceK190050 Tech Dots - Adhesive and conductive gelSpes Medica Srl · 2019
- Descendant · cites it directly · 2 of its ownK192606 SAC2 - Electrode CreamSpes Medica Srl · 2020
- Descendant · cites it directly · 1 of its ownK200402 DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK222770 Conductive GelTop-Rank Health Care Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK212325 EEG-acpSomnomedics GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK212326 AC Cream - Conductive pasteSpes Medica Srl · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192606SAC2 - Electrode CreamSpes Medica Srl · 2020 · cites it directly2descendants
- K200402DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd. · 2020 · cites it directly1descendant
- K222770Conductive GelTop-Rank Health Care Co., Ltd. · 2022 · 2 generations on0descendants
- K212325EEG-acpSomnomedics GmbH · 2022 · 2 generations on0descendants
- K212326AC Cream - Conductive pasteSpes Medica Srl · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983964 | Batch #6060 Conductive Gel | Skylark Device Co., Ltd. | 1998 | — |
| −3 | K022006 | Conductive Gel | The Dezac Group | 2002 | — |
| −2 | K033052 | Conductive Eeg Electrolyte | Compumedics USA, Ltd. | 2003 | — |
| −1 | K111717 | Electro-Gel | Electro-Cap Intl., Inc. | 2012 | — |
| 0 (this device) | K190050 | Tech Dots - Adhesive and conductive gel | Spes Medica Srl | 2019 | — |
| +1 | K192606 | SAC2 - Electrode Cream | Spes Medica Srl | 2020 | — |
| +1 | K200402 | DR-HO'S Electro Therapy Conductive Gel | Guangzhou Xinbo Electronic Co., Ltd. | 2020 | — |
| +2 | K222770 | Conductive Gel | Top-Rank Health Care Co., Ltd. | 2022 | — |
| +2 | K212325 | EEG-acp | Somnomedics GmbH | 2022 | — |
| +2 | K212326 | AC Cream - Conductive paste | Spes Medica Srl | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K111717 | Electro-GelSummary page 4…GYB Classification Regulation: 882.1275 Predicate Device: Electro-Gel 510(k) number: K111717 Device Description: Tech Dots are conductive gel dots to be used with external electrodes as the… | 2012 |
What descends from it? (6)
3 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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 7.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K192606 (Spes Medica Srl, 2020) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K111717.
How does its category compare?
All GYB devicesGYB Media, Electroconductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Tech Dots are intended for use in clinical and research EEG/EP recordings from humans. They are used with external
electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface
and the skin
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190050: Tech Dots - Adhesive and 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/K190050
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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