510(k) · Cleared
ClearedReusable Cutaneous Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ampcare, LLC · GXY Electrode, Cutaneous
Cleared on Oct 15, 2012 as substantially equivalent to K915333 (Labeltape Meditect, Inc., 1992) and 3 other predicates after a 150-day review. Its family tree reaches back 5 generations to 1987. 1 later device descends from it.
- Decided
- Oct 15, 2012
- Review
- 150 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K871222 (1987). 12 ancestors in all, the oldest K852267 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK871222 Tantone Multi-Day #633 Tens ElectrodeUni-Patch, Inc. · 1987
- 4 generations backK983097 Tens/Fes/Nmes ElectrodesUni-Patch, Inc. · 1999
- 3 generations backK070807 Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc. · 2007
- 2 generations backK080386 Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC · 2008
- 1 generation backK083756 Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009
- This deviceK121483 Reusable Cutaneous ElectrodeAmpcare, LLC · 2012
- Descendant · cites it directly · 0 of its ownK172887 XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II…Guangzhou Xinbo Electronic Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…Guangzhou Xinbo Electronic Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871222 | Tantone Multi-Day #633 Tens Electrode | Uni-Patch, Inc. | 1987 | — |
| −4 | K983097 | Tens/Fes/Nmes Electrodes | Uni-Patch, Inc. | 1999 | — |
| −3 | K070807 | Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes | Pepin Mfg., Inc. | 2007 | — |
| −2 | K080386 | Columbia 600 Electrode, Columbia 06 Leadwire | Columbia Scientific Development, LLC | 2008 | — |
| −1 | K083756 | Guardian 150 Electrode | Selectivemed Components, Inc. | 2009 | — |
| 0 (this device) | K121483 | Reusable Cutaneous Electrode | Ampcare, LLC | 2012 | — |
| +1 | K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck… | Guangzhou Xinbo Electronic Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K915333 | Electrode Using Promeon RG-60 Series GelSummary page 1…utaneous Electrode Common Name: Cutaneous Electrode Classification Name: OXY 882.1320 Electrode, Cutaneous Predicate Devices: K915333 GXY Labeltape Meditect, Inc. (Uni-Patch /Covidien) K080386 OXY Columbia Sc… | 1992 |
| * | K080386 | Columbia 600 Electrode, Columbia 06 LeadwireSummary page 1…882.1320 Electrode, Cutaneous Predicate Devices: K915333 GXY Labeltape Meditect, Inc. (Uni-Patch /Covidien) K080386 OXY Columbia Scientific Development, LLC K852267 GXY Axelgaard Manufacturi… | 2008 |
| * | K852267 | Electrical Nerve Stimulation (Tens) ElectrodesSummary page 1…Labeltape Meditect, Inc. (Uni-Patch /Covidien) K080386 OXY Columbia Scientific Development, LLC K852267 GXY Axelgaard Manufacturing Company, Ltd. K083756 GXY SelectiveMed Compone… | 1985 |
| * | K083756 | Guardian 150 ElectrodeSummary page 1…OXY Columbia Scientific Development, LLC K852267 GXY Axelgaard Manufacturing Company, Ltd. K083756 GXY SelectiveMed Components, Inc. (Guardian) Device Description: The new AMPCARE 50709 Series Electrodes de… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -… | 2018 | 0 |
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 25 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K172887 (Guangzhou Xinbo Electronic Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K915333.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
AMPCARE 50709 Series of cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulation current applications of these electrodes are:
a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief
b) Electrical muscle stimulation (EMS) for neck muscle stimulation.
c) Functional electrical stimulation (FES)
d) Galvanic stimulation.
e) Microcurrent electrical nerve stimulation (MENS).
f) Interferential (IF) stimulation.
g) Neuromuscular electrical stimulation (NMES), including for muscle re-education by application of external stimulation to the muscles necessary for phatyngeal contraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121483: Reusable Cutaneous Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121483
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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