510(k) · Cleared
ClearedSAC2 - Electrode Cream
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 Jan 17, 2020 as substantially equivalent to K190050 (Spes Medica Srl, 2019) after a 119-day review. Its family tree reaches back 5 generations to 1998. 2 later devices descend from it.
- Decided
- Jan 17, 2020
- Review
- 119 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K983964 (1998). 8 ancestors in all, the oldest K780045 (1978). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK192606 SAC2 - Electrode CreamSpes Medica Srl · 2020
- Descendant · cites it directly · 0 of its ownK212325 EEG-acpSomnomedics GmbH · 2022
- Descendant · cites it directly · 0 of its ownK212326 AC Cream - Conductive pasteSpes Medica Srl · 2021
Most influential descendants
Showing 2 of 2 · See allView 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) | K192606 | SAC2 - Electrode Cream | Spes Medica Srl | 2020 | — |
| +1 | K212325 | EEG-acp | Somnomedics GmbH | 2022 | — |
| +1 | 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K190050 | Tech Dots - Adhesive and conductive gelSummary page 4…on Regulation: 882.1275 Predicate Device: Tech Dots – Adhesive and Conductive Gel 510(k) number: K190050 Device Description: SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It… | 2019 |
What descends from it? (2)
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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K212325 (Somnomedics GmbH, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K190050.
How does its category compare?
All GYB devicesGYB Media, Electroconductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is 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 as stated in the FDA summary.
https://510kreport.com/device/K192606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192606: SAC2 - Electrode Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192606
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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