510(k) · Cleared
ClearedCup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technomed Europe · GXY Electrode, Cutaneous
Cleared on Oct 19, 2007 as substantially equivalent to K061148 (Rhythmlink International, LLC, 2006) after an 88-day review. Its family tree reaches back 2 generations to 1995. 6 later devices descend from it.
- Decided
- Oct 19, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942921 (1995). 3 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK942921 Neurolink Eeg/EP/Emg Surface ElectrodesNeuro Supplies, Inc. · 1995
- 1 generation backK061148 Rhythmlink Disc ElectrodesRhythmlink International, LLC · 2006
- This deviceK072016 Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes…Technomed Europe · 2007
- Descendant · cites it directly · 1 of its ownK192564 Disposable Gold Cup EEG ElectrodesDymedix Diagnostics, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK190416 Dome ElectrodeCoapt, LLC · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK261442 Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable…Cadwell Industries, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK254183 MR Conditional Cup ElectrodesTechnomed Europe · 2026
- Descendant · 2 generations on · 0 of its ownK223605 ControlSeal Electrode (ELSB)Coapt · 2022 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192564Disposable Gold Cup EEG ElectrodesDymedix Diagnostics, Inc. · 2020 · cites it directly1descendant
- K190416Dome ElectrodeCoapt, LLC · 2019 · cites it directly1descendant
- K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc. · 2026 · cites it directly0descendants
- K254183MR Conditional Cup ElectrodesTechnomed Europe · 2026 · cites it directly0descendants
- K223605ControlSeal Electrode (ELSB)Coapt · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942921 | Neurolink Eeg/EP/Emg Surface Electrodes | Neuro Supplies, Inc. | 1995 | — |
| −1 | K061148 | Rhythmlink Disc Electrodes | Rhythmlink International, LLC | 2006 | — |
| 0 (this device) | K072016 | Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver… | Technomed Europe | 2007 | — |
| +1 | K192564 | Disposable Gold Cup EEG Electrodes | Dymedix Diagnostics, Inc. | 2020 | — |
| +1 | K190416 | Dome Electrode | Coapt, LLC | 2019 | 1 |
| +1 | K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface… | Cadwell Industries, Inc. | 2026 | — |
| +1 | K254183 | MR Conditional Cup Electrodes | Technomed Europe | 2026 | — |
| +2 | K223605 | ControlSeal Electrode (ELSB) | Coapt | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K061148 | Rhythmlink Disc ElectrodesSummary page 1…ification Name: Cutaneous Electrode is classified as class 11 per 21 CER section 882.1320. Product code GXY. Substantial Equivalence: K061 148: Rhythmnlink Disc Electrodes Device description: A cutaneous electrode is an electrode that is applied directly to… | 2006 |
What descends from it? (6)
4 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 12 years and passes through 3 companies; a new generation was cleared every 11.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K192564 (Dymedix Diagnostics, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K061148.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072016 · printed Nov 3, 2026
Cite this page
510(k) Report. “K072016: Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K072016
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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