510(k) · Cleared
Recalled · Class II · 2023ControlSeal Electrode (ELSB)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coapt · GXY Electrode, Cutaneous
Cleared on Dec 30, 2022 as substantially equivalent to K190416 (Coapt, LLC, 2019) after a 28-day review. Its family tree reaches back 4 generations to 1995. It has been recalled once.
- Decided
- Dec 30, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- GXY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K942921 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK942921 Neurolink Eeg/EP/Emg Surface ElectrodesNeuro Supplies, Inc. · 1995
- 3 generations backK061148 Rhythmlink Disc ElectrodesRhythmlink International, LLC · 2006
- 2 generations backK072016 Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes…Technomed Europe · 2007
- 1 generation backK190416 Dome ElectrodeCoapt, LLC · 2019 · Recalled
- This deviceK223605 ControlSeal Electrode (ELSB)Coapt · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942921 | Neurolink Eeg/EP/Emg Surface Electrodes | Neuro Supplies, Inc. | 1995 | — |
| −3 | K061148 | Rhythmlink Disc Electrodes | Rhythmlink International, LLC | 2006 | — |
| −2 | K072016 | Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver… | Technomed Europe | 2007 | — |
| −1 | K190416 | Dome Electrode | Coapt, LLC | 2019 | 1 |
| 0 (this device) | K223605 | ControlSeal Electrode (ELSB) | Coapt | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (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 |
|---|---|---|---|
| * | K190416 | Dome ElectrodeSummary page 5…Comparison Trade Name: ControlSeal Electrode Dome Electrode 510(k) Number TBD K190416 Not applicable Classification GXY GXY Same Product Co… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2023 | Class II | Z-0204-2024 | Process design | Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 11.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 ControlSeal Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223605: ControlSeal Electrode (ELSB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223605
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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