510(k) · Cleared
ClearedHome Care Various Models of Self-Adhesive Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Home Care Technology Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Mar 4, 2003 after a 182-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 23 later devices descend from it.
- Decided
- Mar 4, 2003
- Review
- 182 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 1 citing it directly.
- This deviceK022917 Home Care Various Models of Self-Adhesive ElectrodesHome Care Technology Co., Ltd. · 2003
- Descendant · cites it directly · 22 of its ownK050788 EverlifeEverlife Medical Instrument Co., Ltd. · 2005
- Descendant · 2 generations on · 21 of its ownK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
- Descendant · 3 generations on · 14 of its ownK083302 Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009
- Descendant · 4 generations on · 10 of its ownK130987 Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013
- Descendant · 5 generations on · 5 of its ownK150971 Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K050788EverlifeEverlife Medical Instrument Co., Ltd. · 2005 · cites it directly22descendants
- K062675Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double…Gemore Technology Co, Ltd. · 2007 · 2 generations on21descendants
- K083302Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009 · 3 generations on14descendants
- K130987Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013 · 4 generations on10descendants
- K150971Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022917 | Home Care Various Models of Self-Adhesive Electrodes | Home Care Technology Co., Ltd. | 2003 | — |
| +1 | K050788 | Everlife | Everlife Medical Instrument Co., Ltd. | 2005 | — |
| +2 | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and… | Gemore Technology Co, Ltd. | 2007 | — |
| +3 | K083302 | Lifecare Electrodes | Everyway Medical Instruments Co.,Ltd | 2009 | — |
| +4 | K130987 | Valutrode Neurostimlation Electrodes | Axelgaard Mfg. Co., Ltd. | 2013 | — |
| +5 | K150971 | Zekang Self-adhesive Electrode | Jiangsu Zekang Medical Technology Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050788 | Everlife | 2005 | 22 |
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, K050788 (Everlife Medical Instrument Co., Ltd., 2005) has gone furthest, with 22 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?
Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022917: Home Care Various Models of Self-Adhesive Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022917
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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