510(k) · Cleared
ClearedTEN20 Conductive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weaver & Co. · GYB Media, Electroconductive
Cleared on Sep 28, 1988 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Sep 28, 1988
- Review
- 64 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK883149 TEN20 ConductiveWeaver & Co. · 1988
- Descendant · cites it directly · 9 of its ownK033052 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
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 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883149 | TEN20 Conductive | Weaver & Co. | 1988 | — |
| +1 | 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 | — |
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), 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 11.0 · 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 has not posted a summary or statement for it, so its predicates are not known.
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?
- 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 | — |
https://510kreport.com/device/K883149 · printed Nov 3, 2026
Cite this page
510(k) Report. “K883149: TEN20 Conductive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K883149
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026