510(k) · Cleared
ClearedPals Platinum Neurostimulation Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axelgaard Mfg. Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Feb 13, 2014 as substantially equivalent to K874469 (Axelgaard Mfg. Co., Ltd., 1988) and 2 other predicates after a 192-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Feb 13, 2014
- Review
- 192 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K945676 (1995). 12 ancestors in all, the oldest K874469 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 5 generations backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
- 4 generations backK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
- 3 generations backK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
- 2 generations backK083302 Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009
- 1 generation backK130987 Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013
- This deviceK132422 Pals Platinum Neurostimulation ElectrodesAxelgaard Mfg. Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945676 | Guardian Disposable Tens and Tens/Nmes Electrodes | Selectivemed Components, Inc. | 1995 | — |
| −5 | K050469 | EZ-Stik Electrodes | Naimco, Inc. | 2005 | 4 |
| −4 | K052875 | Prostim Reusable Neurostimulation Electrodes | Summit Manufacturing, LLC | 2005 | — |
| −3 | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and… | Gemore Technology Co, Ltd. | 2007 | — |
| −2 | K083302 | Lifecare Electrodes | Everyway Medical Instruments Co.,Ltd | 2009 | — |
| −1 | K130987 | Valutrode Neurostimlation Electrodes | Axelgaard Mfg. Co., Ltd. | 2013 | — |
| 0 (this device) | K132422 | Pals Platinum Neurostimulation Electrodes | Axelgaard Mfg. Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K874469 | Transcutaneous Electric Nerve Stimulation (Tens)Summary page 1…Date Cleared, ____ ____ ____ ___No.: ___ PALS® Flex Neurostimulation Electrodes Axelgaard Manufacturing Co., Ltd. K874469 1998 Life Care Electrodes Everyway Medical Instruments Co. K083302 2009 Valurode® Neur… | 1988 |
| * | K083302 | Lifecare ElectrodesSummary page 1…Over the Counter Neurostiniulation Electrodes (K1 3987) with the same conductive hydrogel, and electrode carrier. Everyway Medical manufactures the Lifecare Electrode (K083302) with the same conductive hydrogel and conductive carbon film as Axelgaard's Valurodle Neurostimulation Electrodes (K130987). Axe… | 2009 |
| * | K130987 | Valutrode Neurostimlation ElectrodesSummary page 1…Medical manufactures the Lifecare Electrode (K083302) with the same conductive hydrogel and conductive carbon film as Axelgaard's Valurodle Neurostimulation Electrodes (K130987). Axelgaard Manufacturing supplies these components to Everyway. Intended Use (807.92[a] [5]) PALS® reusable, self-adhering, o… | 2013 |
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 19 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
PALS® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132422: Pals Platinum Neurostimulation Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132422
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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