510(k) · Cleared
ClearedGT5 conductive & abrasive gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhan Greentek Pty, Ltd. · GYB Media, Electroconductive
Cleared on Nov 8, 2021 as substantially equivalent to K111717 (Electro-Cap Intl., Inc., 2012) and 3 other predicates after a 68-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Nov 8, 2021
- Review
- 68 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K983964 (1998). 10 ancestors in all, the oldest K780045 (1978). No later device cites it as a predicate yet.
- Root · 5 generations backK983964 Batch #6060 Conductive GelSkylark Device Co., Ltd. · 1998
- 4 generations backK022006 Conductive GelThe Dezac Group · 2002
- 3 generations backK033052 Conductive Eeg ElectrolyteCompumedics USA, Ltd. · 2003
- 2 generations backK111717 Electro-GelElectro-Cap Intl., Inc. · 2012
- 1 generation backK190050 Tech Dots - Adhesive and conductive gelSpes Medica Srl · 2019
- This deviceK212787 GT5 conductive & abrasive gelWuhan Greentek Pty, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983964 | Batch #6060 Conductive Gel | Skylark Device Co., Ltd. | 1998 | — |
| −4 | K022006 | Conductive Gel | The Dezac Group | 2002 | — |
| −3 | K033052 | Conductive Eeg Electrolyte | Compumedics USA, Ltd. | 2003 | — |
| −2 | K111717 | Electro-Gel | Electro-Cap Intl., Inc. | 2012 | — |
| −1 | K190050 | Tech Dots - Adhesive and conductive gel | Spes Medica Srl | 2019 | — |
| 0 (this device) | K212787 | GT5 conductive & abrasive gel | Wuhan Greentek Pty, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 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? (4)
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…882.1275 Classification Name: Media, Electroconductive Regulation Class: Class II Product Code: GYB 3. Predicate Device 510(K) number: K111717 Device Name: Eletro-Gel Manufacturer: Electro-Cap International, Inc. Regulations: 21 CFR 8… | 2012 |
| * | K190050 | Tech Dots - Adhesive and conductive gelSummary page 4…21 CFR 882.1275 Classification Name: Media, Electroconductive Regulation Class: Class II Product Code: GYB 510(K) number: K190050 Device Name: Tech Dots – Adhesive and Conductive Gel Manufacturer: Spes Medica S.r.l. Regulations:… | 2019 |
| * | K970694 | Model 1700, Hydro PrepSummary page 4…21 CFR 882.1275 Classification Name: Media, Electroconductive Regulation Class: Class II Product Code: GYB 510(K) number: K970694 Device Name: Model 1700, HydroPrep… | 1997 |
| * | K885306 | NuprepSummary page 5…: 21 CFR 882.1275 Classification Name: Media, Electroconductive Regulation Class: Class II Product Code: GYB 510(K) number: K885306 Device Name: NuPrep Manufacturer: WEAVER & COMPANY Regulations: 21 CFR 870.2360 Classification… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 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. 2021, 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?
GTS5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance (resistance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. GT5 conductive & abrasive gel is not intended for use with stimulating electrodes.
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/K212787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212787: GT5 conductive & abrasive gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212787
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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