510(k) · Cleared
ClearedComby EEG Caps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pamel D.O.O · GXY Electrode, Cutaneous
Cleared on Nov 9, 2021 as substantially equivalent to K112319 (Electro-Cap Intl., Inc., 2012) and 2 other predicates after a 193-day review. Its family tree reaches back 5 generations to 1978.
- Decided
- Nov 9, 2021
- Review
- 193 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K780045 (1978). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK780045 Electrode CapElectro-Cap Intl., Inc. · 1978
- 4 generations backK071446 Electrode Array CapElectrode Arrays · 2008
- 3 generations backK110223 Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011
- 2 generations backK112319 Electro-Cap SystemElectro-Cap Intl., Inc. · 2012
- 1 generation backK200162 Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Wuhan Greentek Pty, Ltd. · 2020
- This deviceK211315 Comby EEG CapsPamel D.O.O · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K780045 | Electrode Cap | Electro-Cap Intl., Inc. | 1978 | — |
| −4 | K071446 | Electrode Array Cap | Electrode Arrays | 2008 | — |
| −3 | K110223 | Waveguard (TM) Eeg Cap | Eemagine Medical Imaging Solutions GmbH | 2011 | — |
| −2 | 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 | — |
| 0 (this device) | K211315 | Comby EEG Caps | Pamel D.O.O | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 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? (3)
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 5…e Disposable EEG Electrodes Wave Guard Eemagine Medi- Arrays (Predicate) 510(k) (MODEL: DL, E-CAP, cal (Predicate) 510(k) #K112319 FLEX-CAP DEVICE #K110223 K200162 Electro-… | 2012 |
| * | K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Summary page 5…DL, E-CAP, cal (Predicate) 510(k) #K112319 FLEX-CAP DEVICE #K110223 K200162 Electro-Cap International Inc Wuhan Greentek Pty Ltd. EEMAGINE MEDICAL IM- 011 W Lexington Rd, Eaton,… | 2020 |
| * | K110223 | Waveguard (TM) Eeg CapSummary page 5…Arrays (Predicate) 510(k) (MODEL: DL, E-CAP, cal (Predicate) 510(k) #K112319 FLEX-CAP DEVICE #K110223 K200162 Electro-Cap International Inc Wuhan Greentek Pty Ltd. EEMAGINE… | 2011 |
| † | K111717 | Electro-Gel | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 43 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 6 ancestors has a recall.
- 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. 2021, 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 Comby EEG Cap is intended for use in routine clinical settings where rapid placement of large 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/K211315 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211315: Comby EEG Caps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211315
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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