510(k) · Cleared
ClearedGold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and Conductive Plastic Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ives Eeg Solutions, Inc. · GXY Electrode, Cutaneous
Cleared on Sep 7, 2007 as substantially equivalent to K032278 (Ambu, Inc., 2004) and 1 other predicate after a 140-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Sep 7, 2007
- Review
- 140 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022197 (2002). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK022197 Surface Electrode for ElectroencephalographyThe Electrode Store, Inc. · 2002
- This deviceK071118 Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL…Ives Eeg Solutions, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK171102 Ives MR Conditional Cup ElectrodeIves Egg Solutions · 2017
- Descendant · cites it directly · 0 of its ownK163547 MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96Neurovirtual USA, Inc. · 2017
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 |
|---|---|---|---|---|---|
| −1 | K022197 | Surface Electrode for Electroencephalography | The Electrode Store, Inc. | 2002 | — |
| 0 (this device) | K071118 | Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating… | Ives Eeg Solutions, Inc. | 2007 | — |
| +1 | K171102 | Ives MR Conditional Cup Electrode | Ives Egg Solutions | 2017 | — |
| +1 | K163547 | MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 | Neurovirtual USA, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 GXY? 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 GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K032278 | Ambu Neuroline Single Patient Eeg/EP Cup ElectrodeSummary page 1…ncy, MA Trade Name: Surface EEG Electrode Product Code: GXY Other Predicate 510(k) Number: K032278 Devices: Manufacture: AMBU, Inc. Trade Name: EEG/EP Cup Electrode… | 2004 |
| * | K022197 | Surface Electrode for ElectroencephalographySummary page 1…BU, Inc. Trade Name: EEG/EP Cup Electrode Product Code: GXY 510(k) Number: K022197 Manufacture: The Electrode Store Trade Name: Cutaneous Electrode… | 2002 |
| * | — | Surface EEG Electrode Named without a submission number |
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?
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, 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 | 7 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
The cutaneous, surface cup electrode system is intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071118: Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and Conductive Plastic Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071118
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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