510(k) · Cleared
ClearedMaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovirtual USA, Inc. · GXY Electrode, Cutaneous
Cleared on Apr 11, 2017 as substantially equivalent to K022197 (The Electrode Store, Inc., 2002) and 1 other predicate after a 116-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Apr 11, 2017
- Review
- 116 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022197 (2002). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK022197 Surface Electrode for ElectroencephalographyThe Electrode Store, Inc. · 2002
- 1 generation backK071118 Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL…Ives Eeg Solutions, Inc. · 2007
- This deviceK163547 MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96Neurovirtual USA, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022197 | Surface Electrode for Electroencephalography | The Electrode Store, Inc. | 2002 | — |
| −1 | K071118 | Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating… | Ives Eeg Solutions, Inc. | 2007 | — |
| 0 (this device) | 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 |
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? (2)
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 |
|---|---|---|---|
| * | K022197 | Surface Electrode for Electroencephalography | 2002 |
| * | K071118 | Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and…Summary page 4…Surface Electrode for KO22197 The Electrode Store, Inc. Electroencephalography K071118 EEG Surface Electrode System Ives EEG Solutions, Inc… | 2007 |
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 15 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K022197.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 MaxxiGold Electrode is intended for non-invasive use as recording electrodes in studies of physiological signals.
These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163547 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163547: MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163547
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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