510(k) · Cleared
ClearedElectrode Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electro-Cap Intl., Inc. · GXY Electrode, Cutaneous
Cleared on Jan 24, 1978 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 38 devices in its family, counting itself, has a Class I recall. 37 later devices descend from it.
- Decided
- Jan 24, 1978
- Review
- 15 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 8 citing it directly. 1 of the 38 devices in this family, counting this one, has a Class I recall.
- This deviceK780045 Electrode CapElectro-Cap Intl., Inc. · 1978
- Descendant · cites it directly · 19 of its ownK071446 Electrode Array CapElectrode Arrays · 2008
- Descendant · cites it directly · 18 of its ownK110223 Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011
- Descendant · cites it directly · 16 of its ownK112319 Electro-Cap SystemElectro-Cap Intl., Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK200162 Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Wuhan Greentek Pty, Ltd. · 2020
- Descendant · cites it directly · 8 of its ownK111717 Electro-GelElectro-Cap Intl., Inc. · 2012
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131882 Geodesiceeg System 400 Series (Ges 400)3 generations on · 2014
Most influential descendants
Showing 5 of 37 · See all- K071446Electrode Array CapElectrode Arrays · 2008 · cites it directly19descendants
- K110223Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011 · cites it directly18descendants
- K112319Electro-Cap SystemElectro-Cap Intl., Inc. · 2012 · cites it directly16descendants
- K200162Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Wuhan Greentek Pty, Ltd. · 2020 · 2 generations on9descendants
- K111717Electro-GelElectro-Cap Intl., Inc. · 2012 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K780045 | Electrode Cap | Electro-Cap Intl., Inc. | 1978 | — |
| +1 | K071446 | Electrode Array Cap | Electrode Arrays | 2008 | — |
| +1 | K110223 | Waveguard (TM) Eeg Cap | Eemagine Medical Imaging Solutions GmbH | 2011 | — |
| +1 | K112319 | Electro-Cap System | Electro-Cap Intl., Inc. | 2012 | — |
| +2 | K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | Wuhan Greentek Pty, Ltd. | 2020 | — |
| +1 | K111717 | Electro-Gel | Electro-Cap Intl., Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 1 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (37)
See all 378 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071446 | Electrode Array Cap | 2008 | 19 |
| K110223 | Waveguard (TM) Eeg Cap | 2011 | 18 |
| K112319 | Electro-Cap System | 2012 | 16 |
| K111717 | Electro-Gel | 2012 | 8 |
| K012079 | Geodesic Eeg System, Model 200 | 2001 | 4 |
| K162460 | WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts | 2017 | 1 |
| K043009 | Brainet Kit | 2005 | 1 |
| K021986 | Brainet | 2002 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K131882Geodesiceeg System 400 Series (Ges 400)Electrical Geodesics, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K071446 (Electrode Arrays, 2008) has gone furthest, with 19 descendants of its own.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K780045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K780045: Electrode Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780045
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026