510(k) · Cleared
ClearedLong Life Padtm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · GXY Electrode, Cutaneous
Cleared on May 17, 2012 as substantially equivalent to K082065 (Well-Life Healthcare Limited, 2009) after an 86-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- May 17, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945676 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 4 generations backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
- 3 generations backK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
- 2 generations backK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
- 1 generation backK082065 Well Life Self Adhesive Electrode / Models: CM, FA, PU and SPWell-Life Healthcare Limited · 2009
- This deviceK120516 Long Life PadtmOmron Healthcare, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945676 | Guardian Disposable Tens and Tens/Nmes Electrodes | Selectivemed Components, Inc. | 1995 | — |
| −4 | K050469 | EZ-Stik Electrodes | Naimco, Inc. | 2005 | 4 |
| −3 | K052875 | Prostim Reusable Neurostimulation Electrodes | Summit Manufacturing, LLC | 2005 | — |
| −2 | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and… | Gemore Technology Co, Ltd. | 2007 | — |
| −1 | K082065 | Well Life Self Adhesive Electrode / Models: CM, FA, PU and SP | Well-Life Healthcare Limited | 2009 | — |
| 0 (this device) | K120516 | Long Life Padtm | Omron Healthcare, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K082065 | Well Life Self Adhesive Electrode / Models: CM, FA, PU and SPSummary page 1…Long Life PadThI Predicate Device: Well Life Healthcare Limited - Well-Life Self Adhesive Electrodes K082065 Device Description: The LONG LIFE PADm is intended for use as a disposable, conductive adhesive interface between the patient's… | 2009 |
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 17 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 1 other device also cites its predicate K082065.
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?
The LONG LIFE PADM is intended for use as a disposable, conductive adhesive
interface between the patient's skin and the Electrical Stimulator. These pads should be
used only with the Oniron Electrotherapy Pain Relief Unit, (PM3030) and applied on
normal, healthy, dry, clean skin of adults.
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/K120516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120516: Long Life Padtm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120516
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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