510(k) · Cleared
ClearedGmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM, CWN1007.Dia. 7CM, CWN2509,5CMX9CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gmdasz Manufacturing Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Dec 18, 2009 as substantially equivalent to K970426 (Axelgaard Mfg. Co., Ltd., 1997) and 1 other predicate after a 121-day review. Its family tree reaches back 2 generations to 1995. 16 later devices descend from it.
- Decided
- Dec 18, 2009
- Review
- 121 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945676 (1995). 4 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 1 generation backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
- This deviceK092546 Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM…Gmdasz Manufacturing Co., Ltd. · 2009
- Descendant · cites it directly · 15 of its ownK160138 Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016
- Descendant · 2 generations on · 9 of its ownK180865 ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd. · 2018
- Descendant · 2 generations on · 6 of its ownK222252 Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd. · 2023
- Descendant · 3 generations on · 5 of its ownK223802 accufitMettler Electronics Corporation · 2023
- Descendant · 4 generations on · 4 of its ownK233926 accufitMettler Electronics Corporation · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016 · cites it directly15descendants
- K180865ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd. · 2018 · 2 generations on9descendants
- K222252Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd. · 2023 · 2 generations on6descendants
- K223802accufitMettler Electronics Corporation · 2023 · 3 generations on5descendants
- K233926accufitMettler Electronics Corporation · 2024 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945676 | Guardian Disposable Tens and Tens/Nmes Electrodes | Selectivemed Components, Inc. | 1995 | — |
| −1 | K050469 | EZ-Stik Electrodes | Naimco, Inc. | 2005 | 4 |
| 0 (this device) | K092546 | Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM… | Gmdasz Manufacturing Co., Ltd. | 2009 | — |
| +1 | K160138 | Adhesive Electrodes | Gmdasz Manufacturing Co., Ltd. | 2016 | — |
| +2 | K180865 | ZMI Self-Adhesive Electrodes | Zmi Electronics, Ltd. | 2018 | — |
| +2 | K222252 | Self-adhesive Electrode | Shenzhen Roundwhale Technology Co., Ltd. | 2023 | — |
| +3 | K223802 | accufit | Mettler Electronics Corporation | 2023 | — |
| +4 | K233926 | accufit | Mettler Electronics Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K970426 | ValuetrodeSummary page 1…M odel__ _ _ _ _ _ _ __ _ _ _ _ _ ValuTrode Axelgaad K970426 Manufacturing Co., GIVDASZ TENS Electrodes… | 1997 |
| * | K050469 | EZ-Stik ElectrodesSummary page 1…_ _ _ __ _ __ _ __ _ _ Ltd _ _ _ _ _ _ _ _ _ EZ-Stik NAlmco, Inc. K050469 GMVDASZ TENS Electrodes Page 20… | 2005 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160138 | Adhesive Electrodes | 2016 | 15 |
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 14 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K160138 (Gmdasz Manufacturing Co., Ltd., 2016) has gone furthest, with 15 descendants of its own.
- 5 other devices also cite its predicate K970426.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 GMDASZ TENS Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. GMDASZ's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).
The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092546: Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM, CWN1007.Dia. 7CM, CWN2509,5CMX9CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092546
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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