510(k) · Cleared
ClearedElectrode Market Disposable Surface Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electrode Market Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Jul 28, 2021 as substantially equivalent to K073532 (Technomed Europe, 2008) after a 44-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Jul 28, 2021
- Review
- 44 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971914 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK971914 Teca NCS Electrode System 2000Medelec, Inc. D.B.A. Teca Corp. · 1998
- 1 generation backK073532 Disposable Adhesive Surface Electrodes, Disc ElectrodesTechnomed Europe · 2008
- This deviceK211839 Electrode Market Disposable Surface ElectrodesElectrode Market Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971914 | Teca NCS Electrode System 2000 | Medelec, Inc. D.B.A. Teca Corp. | 1998 | — |
| −1 | K073532 | Disposable Adhesive Surface Electrodes, Disc Electrodes | Technomed Europe | 2008 | — |
| 0 (this device) | K211839 | Electrode Market Disposable Surface Electrodes | Electrode Market Co., Ltd. | 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? (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 |
|---|---|---|---|
| * | K073532 | Disposable Adhesive Surface Electrodes, Disc ElectrodesSummary page 5…ion of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission is shown as follows: 510(k) Number: K073532 Applicant: Technomed Europe Regulation Name: Cutaneous electrode Device… | 2008 |
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 23 years and passes through 3 companies; a new generation was cleared every 13.2 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K073532.
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 Electrode Market Disposable Surface Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP). The electrodes are designed for single use.
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/K211839 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211839: Electrode Market Disposable Surface Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211839
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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