510(k) · Cleared
ClearedElectro-Cap System
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 27, 2012 as substantially equivalent to K780045 (Electro-Cap Intl., Inc., 1978) and 3 other predicates after a 169-day review. Its family tree reaches back 3 generations to 1978. 16 later devices descend from it.
- Decided
- Jan 27, 2012
- Review
- 169 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K780045 (1978). 4 ancestors in all. 16 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK780045 Electrode CapElectro-Cap Intl., Inc. · 1978
- 2 generations backK071446 Electrode Array CapElectrode Arrays · 2008
- 1 generation backK110223 Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011
- This deviceK112319 Electro-Cap SystemElectro-Cap Intl., Inc. · 2012
- Descendant · cites it directly · 9 of its ownK200162 Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Wuhan Greentek Pty, Ltd. · 2020
- Descendant · 2 generations on · 5 of its ownK210805 Ceribell Instant EEG HeadbandCeribell, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK232052 Ceribell Instant EEG HeadbandCeribell, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK223086 Ceribell Instant EEG HeadcapCeribell, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK171669 g.Nautilus PROG.Tec Medical Engineering GmbH · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K200162Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Wuhan Greentek Pty, Ltd. · 2020 · cites it directly9descendants
- K210805Ceribell Instant EEG HeadbandCeribell, Inc. · 2021 · 2 generations on5descendants
- K232052Ceribell Instant EEG HeadbandCeribell, Inc. · 2023 · 3 generations on3descendants
- K223086Ceribell Instant EEG HeadcapCeribell, Inc. · 2023 · 2 generations on3descendants
- K171669g.Nautilus PROG.Tec Medical Engineering GmbH · 2017 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K780045 | Electrode Cap | Electro-Cap Intl., Inc. | 1978 | — |
| −2 | K071446 | Electrode Array Cap | Electrode Arrays | 2008 | — |
| −1 | K110223 | Waveguard (TM) Eeg Cap | Eemagine Medical Imaging Solutions GmbH | 2011 | — |
| 0 (this device) | K112319 | Electro-Cap System | Electro-Cap Intl., Inc. | 2012 | — |
| +1 | K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | Wuhan Greentek Pty, Ltd. | 2020 | — |
| +2 | K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2021 | — |
| +3 | K232052 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2023 | — |
| +2 | K223086 | Ceribell Instant EEG Headcap | Ceribell, Inc. | 2023 | — |
| +1 | K171669 | g.Nautilus PRO | G.Tec Medical Engineering GmbH | 2017 | — |
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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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? (4)
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…19, 2012 Electro-Cap System EEG Electrode Positioning System Electrode, Cutaneous 21 CFR 882.1320 JAN 2 7 2012 Product Code: GXY Predicate Device(s): 510(k) Number: K780045 Manufacture: Electro-Cap International, Inc. Trade Name: Electro-Cap System 510(k) Number: K071446 Manufacture: Electrode Arrays… | 1978 |
| * | K071446 | Electrode Array CapSummary page 1…JAN 2 7 2012 Product Code: GXY Predicate Device(s): 510(k) Number: K780045 Manufacture: Electro-Cap International, Inc. Trade Name: Electro-Cap System 510(k) Number: K071446 Manufacture: Electrode Arrays Trade Name: Electrode Array Cap 510(k) Number: K000865 Manufacture: Neuroscan (Neurosoft, Inc.) T… | 2008 |
| * | K000865 | Quik-CapSummary page 1…re: Electro-Cap International, Inc. Trade Name: Electro-Cap System 510(k) Number: K071446 Manufacture: Electrode Arrays Trade Name: Electrode Array Cap 510(k) Number: K000865 Manufacture: Neuroscan (Neurosoft, Inc.) Trade Name: Quik-Cap EEG Electrode Positioning System Cap 510(k) Number: K110223 Manufa… | 2000 |
| * | K110223 | Waveguard (TM) Eeg CapSummary page 1…ade Name: Electrode Array Cap 510(k) Number: K000865 Manufacture: Neuroscan (Neurosoft, Inc.) Trade Name: Quik-Cap EEG Electrode Positioning System Cap 510(k) Number: K110223 Manufacture: Eemagine Mcdical Imaging Solutions GmbH Trade Name: WaveGuard EEG Cap 1.0 Description of Device The Electro-Cap Sys… | 2011 |
What descends from it? (16)
See all 165 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 34 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K200162 (Wuhan Greentek Pty, Ltd., 2020) has gone furthest, with 9 descendants of its own.
- 7 other devices also cite its predicate K780045.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Electro-Cap System is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112319: Electro-Cap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112319
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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