510(k) · Cleared
ClearedDisposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhan Greentek Pty, Ltd. · GXY Electrode, Cutaneous
Cleared on Apr 21, 2020 as substantially equivalent to K112319 (Electro-Cap Intl., Inc., 2012) after a 90-day review. Its family tree reaches back 4 generations to 1978. 9 later devices descend from it.
- Decided
- Apr 21, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K780045 (1978). 5 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK780045 Electrode CapElectro-Cap Intl., Inc. · 1978
- 3 generations backK071446 Electrode Array CapElectrode Arrays · 2008
- 2 generations backK110223 Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011
- 1 generation backK112319 Electro-Cap SystemElectro-Cap Intl., Inc. · 2012
- This deviceK200162 Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Wuhan Greentek Pty, Ltd. · 2020
- Descendant · cites it directly · 5 of its ownK210805 Ceribell Instant EEG HeadbandCeribell, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK232052 Ceribell Instant EEG HeadbandCeribell, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK223086 Ceribell Instant EEG HeadcapCeribell, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK254033 Ceribell Instant EEG HeadsetCeribell, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK260363 Ceribell Brain Monitor HeadbandCeribell, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K210805Ceribell Instant EEG HeadbandCeribell, Inc. · 2021 · cites it directly5descendants
- K232052Ceribell Instant EEG HeadbandCeribell, Inc. · 2023 · 2 generations on3descendants
- K223086Ceribell Instant EEG HeadcapCeribell, Inc. · 2023 · cites it directly3descendants
- K254033Ceribell Instant EEG HeadsetCeribell, Inc. · 2026 · 2 generations on1descendant
- K260363Ceribell Brain Monitor HeadbandCeribell, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K780045 | Electrode Cap | Electro-Cap Intl., Inc. | 1978 | — |
| −3 | 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 | — |
| 0 (this device) | K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | Wuhan Greentek Pty, Ltd. | 2020 | — |
| +1 | K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2021 | — |
| +2 | K232052 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2023 | — |
| +1 | K223086 | Ceribell Instant EEG Headcap | Ceribell, Inc. | 2023 | — |
| +2 | K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | 2026 | — |
| +3 | K260363 | Ceribell Brain Monitor Headband | Ceribell, Inc. | 2026 | — |
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 |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K112319 | Electro-Cap SystemSummary page 4…ation Name: cutaneous electrode Regulation Class: Class II Product Code: GXY 3. Predicate Device 510(K) number: K112319 Trade Name: Electro-Cap System Common Name EEG electrode positioning system Manufactur… | 2012 |
What descends from it? (9)
3 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?
- The line of descent spans 42 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K210805 (Ceribell, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K112319.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200162: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200162
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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