510(k) · Cleared
ClearedAmbu Neuroline Single Patient Eeg/EP Cup Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu, Inc. · GXY Electrode, Cutaneous
Cleared on Mar 5, 2004 after a 225-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Mar 5, 2004
- Review
- 225 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK032278 Ambu Neuroline Single Patient Eeg/EP Cup ElectrodeAmbu, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK071118 Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL…Ives Eeg Solutions, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK122376 PMT Truscan Surface ElectrodePmt Corp. · 2012
- Descendant · cites it directly · 0 of its ownK200540 BRAINSTREAM Disposable Deep Cup EEG ElectrodesConmed Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK171102 Ives MR Conditional Cup ElectrodeIves Egg Solutions · 2017
- Descendant · 2 generations on · 0 of its ownK163547 MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96Neurovirtual USA, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K071118Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and…Ives Eeg Solutions, Inc. · 2007 · cites it directly2descendants
- K122376PMT Truscan Surface ElectrodePmt Corp. · 2012 · cites it directly1descendant
- K200540BRAINSTREAM Disposable Deep Cup EEG ElectrodesConmed Corporation · 2020 · cites it directly0descendants
- K171102Ives MR Conditional Cup ElectrodeIves Egg Solutions · 2017 · 2 generations on0descendants
- K163547MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96Neurovirtual USA, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032278 | Ambu Neuroline Single Patient Eeg/EP Cup Electrode | Ambu, Inc. | 2004 | — |
| +1 | K071118 | Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating… | Ives Eeg Solutions, Inc. | 2007 | — |
| +1 | K122376 | PMT Truscan Surface Electrode | Pmt Corp. | 2012 | — |
| +1 | K200540 | BRAINSTREAM Disposable Deep Cup EEG Electrodes | Conmed Corporation | 2020 | — |
| +2 | K171102 | Ives MR Conditional Cup Electrode | Ives Egg Solutions | 2017 | — |
| +2 | K163547 | MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 | Neurovirtual USA, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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?
- Of its descendants, K071118 (Ives Eeg Solutions, Inc., 2007) has gone furthest, with 2 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 | — |
What is it indicated for?
The Single Patient EEG/EP Cup Electrode is intended for use with recording,
monitoring and stimulation equipment for the purpose of recording of biopotential
signals for example: Electroencephalograph (EEG) and Nerve potentials signals. The
electrodes are for single patient use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032278 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032278: Ambu Neuroline Single Patient Eeg/EP Cup Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032278
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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