510(k) · Cleared
ClearedDisposable Adhesive Surface Electrodes, Disc Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technomed Europe · GXY Electrode, Cutaneous
Cleared on May 1, 2008 as substantially equivalent to K000870 (Katecho, Inc., 2000) and 1 other predicate after a 136-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- May 1, 2008
- Review
- 136 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971914 (1998). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK971914 Teca NCS Electrode System 2000Medelec, Inc. D.B.A. Teca Corp. · 1998
- This deviceK073532 Disposable Adhesive Surface Electrodes, Disc ElectrodesTechnomed Europe · 2008
- Descendant · cites it directly · 0 of its ownK211839 Electrode Market Disposable Surface ElectrodesElectrode Market Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK180247 DAEHAN Adhesive Surface ElectrodesDaehan Medical Systems Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971914 | Teca NCS Electrode System 2000 | Medelec, Inc. D.B.A. Teca Corp. | 1998 | — |
| 0 (this device) | K073532 | Disposable Adhesive Surface Electrodes, Disc Electrodes | Technomed Europe | 2008 | — |
| +1 | K211839 | Electrode Market Disposable Surface Electrodes | Electrode Market Co., Ltd. | 2021 | — |
| +1 | K180247 | DAEHAN Adhesive Surface Electrodes | Daehan Medical Systems Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K000870 | KM-10 Tens ElectrodeSummary page 1…Cutaneous Electrode is classified as class II per 21 CFR section 882.1320. Product code GXY. Substantial Equivalence: K000870: KM-10 Non-Sterile TENS Electrode K971914: TECA NCS Electrode System 2000 Device descriptio… | 2000 |
| * | K971914 | Teca NCS Electrode System 2000Summary page 1…21 CFR section 882.1320. Product code GXY. Substantial Equivalence: K000870: KM-10 Non-Sterile TENS Electrode K971914: TECA NCS Electrode System 2000 Device description: Disposable Adhesive Surface Electrodes are non-invasive.… | 1998 |
What descends from it? (2)
2 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?
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the, patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073532: Disposable Adhesive Surface Electrodes, Disc Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073532
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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