510(k) · Cleared
ClearedQuik-Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuroscan · GXY Electrode, Cutaneous
Cleared on Apr 18, 2000 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.
- Decided
- Apr 18, 2000
- Review
- 32 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 2 citing it directly.
- This deviceK000865 Quik-CapNeuroscan · 2000
- Descendant · cites it directly · 19 of its ownK071446 Electrode Array CapElectrode Arrays · 2008
- Descendant · 2 generations on · 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
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K071446Electrode Array CapElectrode Arrays · 2008 · cites it directly19descendants
- K110223Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011 · 2 generations on18descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000865 | Quik-Cap | Neuroscan | 2000 | — |
| +1 | K071446 | Electrode Array Cap | Electrode Arrays | 2008 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (20)
See all 202 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?
- 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/K000865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000865: Quik-Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000865
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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