510(k) · Cleared
ClearedElectrode Array Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electrode Arrays · GXY Electrode, Cutaneous
Cleared on Jul 2, 2008 as substantially equivalent to K780045 (Electro-Cap Intl., Inc., 1978) and 1 other predicate after a 405-day review. Its family tree reaches back 1 generation to 1978. 19 later devices descend from it.
- Decided
- Jul 2, 2008
- Review
- 405 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K780045 (1978). 2 ancestors in all. 19 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK780045 Electrode CapElectro-Cap Intl., Inc. · 1978
- This deviceK071446 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 · 3 generations on · 5 of its ownK210805 Ceribell Instant EEG HeadbandCeribell, Inc. · 2021
- Descendant · 4 generations on · 3 of its ownK232052 Ceribell Instant EEG HeadbandCeribell, Inc. · 2023
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- 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
- K210805Ceribell Instant EEG HeadbandCeribell, Inc. · 2021 · 3 generations on5descendants
- K232052Ceribell Instant EEG HeadbandCeribell, Inc. · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K780045 | Electrode Cap | Electro-Cap Intl., Inc. | 1978 | — |
| 0 (this device) | 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 | — |
| +3 | K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2021 | — |
| +4 | K232052 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K780045 | Electrode CapSummary page 1…e: Electrode Positioning Cap Classification Name: Electrode, Metallic with Soft Pad Covering Predicate Device: Electro-Cap 510(k) K780045 Quik-Cap 510(k) K000865 Description of the Device: The Electrode Array Cap comprises an electrode… | 1978 |
| * | K000865 | Quik-CapSummary page 1…ication Name: Electrode, Metallic with Soft Pad Covering Predicate Device: Electro-Cap 510(k) K780045 Quik-Cap 510(k) K000865 Description of the Device: The Electrode Array Cap comprises an electrode placement system for positioning electrodes. The densi… | 2000 |
What descends from it? (19)
See all 192 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. 2008, 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 Electrode Arrays Cap is intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071446: Electrode Array Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071446
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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