510(k) · Cleared
ClearedSoft-Touch Tens Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pain Management Technologies · GXY Electrode, Cutaneous
Cleared on May 5, 2003 as substantially equivalent to K915333 (Labeltape Meditect, Inc., 1992) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- May 5, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915333 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915333 Electrode Using Promeon RG-60 Series GelLabeltape Meditect, Inc. · 1992 · Recalled
- This deviceK030375 Soft-Touch Tens ElectrodePain Management Technologies · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915333 | Electrode Using Promeon RG-60 Series Gel | Labeltape Meditect, Inc. | 1992 | 1 |
| 0 (this device) | K030375 | Soft-Touch Tens Electrode | Pain Management Technologies | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 |
|---|---|---|---|
| * | K915333 | Electrode Using Promeon RG-60 Series GelSummary page 1…e Cutaneous Classification: Class II Product Code: 84gxy Predicate Devices: The k915333 and the k912643 electrodes II. Indications for use: The PMT Soft-TouchTMexternal TENS Electrodes are indicated for use with tran… | 1992 |
| * | K912643 | ElectrodeSummary page 1…ssification: Class II Product Code: 84gxy Predicate Devices: The k915333 and the k912643 electrodes II. Indications for use: The PMT Soft-TouchTMexternal TENS Electrodes are indicated for use with transcutaneous elect… | 1992 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 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.
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 PMT Soft-TouchTMexternal TENS Electrodes are indicated for use with transcutaneous electrical stimulation devices as a non-sterile, disposable device for single patient use only. The PMT electrodes provide the conductive interface between the TENS generator and the patient’s skin.
The PMT TENS electrode Soft-TouchTMare designed for, and to be used with marketed and FDA approved TENS stimulators.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K030375 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030375: Soft-Touch Tens Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030375
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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