510(k) · Cleared
Recalled · Class II · 2012Electrode Using Promeon RG-60 Series Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Labeltape Meditect, Inc. · GXY Electrode, Cutaneous
Cleared on Jan 14, 1992 after a 49-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 14, 1992
- Review
- 49 days
- Class
- Class II
- Product code
- GXY
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK915333 Electrode Using Promeon RG-60 Series GelLabeltape Meditect, Inc. · 1992
- Descendant · cites it directly · 1 of its ownK121483 Reusable Cutaneous ElectrodeAmpcare, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK172887 XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II…Guangzhou Xinbo Electronic Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK030375 Soft-Touch Tens ElectrodePain Management Technologies · 2003
Most influential descendants
Showing 3 of 3 · See all- K121483Reusable Cutaneous ElectrodeAmpcare, LLC · 2012 · cites it directly1descendant
- K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…Guangzhou Xinbo Electronic Co., Ltd. · 2018 · 2 generations on0descendants
- K030375Soft-Touch Tens ElectrodePain Management Technologies · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915333 | Electrode Using Promeon RG-60 Series Gel | Labeltape Meditect, Inc. | 1992 | — |
| +1 | K121483 | Reusable Cutaneous Electrode | Ampcare, LLC | 2012 | — |
| +2 | K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck… | Guangzhou Xinbo Electronic Co., Ltd. | 2018 | — |
| +1 | K030375 | Soft-Touch Tens Electrode | Pain Management Technologies | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 9, 2012 | Class II | Z-0500-2013 | Employee error | Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121483 (Ampcare, LLC, 2012) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K915333 · printed Nov 4, 2026
Cite this page
510(k) Report. “K915333: Electrode Using Promeon RG-60 Series Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915333
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026