510(k) · Cleared
ClearedEEG-acp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnomedics GmbH · GYB Media, Electroconductive
Cleared on Jun 15, 2022 as substantially equivalent to K192606 (Spes Medica Srl, 2020) after a 324-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Jun 15, 2022
- Review
- 324 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K983964 (1998). 9 ancestors in all, the oldest K780045 (1978). No later device cites it as a predicate yet.
- Root · 6 generations backK983964 Batch #6060 Conductive GelSkylark Device Co., Ltd. · 1998
- 5 generations backK022006 Conductive GelThe Dezac Group · 2002
- 4 generations backK033052 Conductive Eeg ElectrolyteCompumedics USA, Ltd. · 2003
- 3 generations backK111717 Electro-GelElectro-Cap Intl., Inc. · 2012
- 2 generations backK190050 Tech Dots - Adhesive and conductive gelSpes Medica Srl · 2019
- 1 generation backK192606 SAC2 - Electrode CreamSpes Medica Srl · 2020
- This deviceK212325 EEG-acpSomnomedics GmbH · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983964 | Batch #6060 Conductive Gel | Skylark Device Co., Ltd. | 1998 | — |
| −5 | K022006 | Conductive Gel | The Dezac Group | 2002 | — |
| −4 | K033052 | Conductive Eeg Electrolyte | Compumedics USA, Ltd. | 2003 | — |
| −3 | K111717 | Electro-Gel | Electro-Cap Intl., Inc. | 2012 | — |
| −2 | K190050 | Tech Dots - Adhesive and conductive gel | Spes Medica Srl | 2019 | — |
| −1 | K192606 | SAC2 - Electrode Cream | Spes Medica Srl | 2020 | — |
| 0 (this device) | K212325 | EEG-acp | Somnomedics GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1988 | 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? (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 |
|---|---|---|---|
| * | K192606 | SAC2 - Electrode CreamSummary page 5…II Product Code: GYB Classification Regulation: 21 CFR 882.1275 Electroconductive Media Predicate Device: SAC2 – Electrode cream (K192606) Device description EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recor… | 2020 |
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 24 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K192606.
How does its category compare?
All GYB devicesGYB Media, Electroconductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from
humans under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with
EEG cup electrodes on the scalp.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212325 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212325: EEG-acp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212325
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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