510(k) · Cleared
ClearedTheratrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phoenix Medical Devices, Llp · GXY Electrode, Cutaneous
Cleared on Jan 25, 2012 as substantially equivalent to K083302 (Everyway Medical Instruments Co.,Ltd, 2009) after a 167-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 25, 2012
- Review
- 167 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. 2 later devices descend from it, 1 citing it directly.
- 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 backK083302 Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009
- This deviceK112312 TheratrodePhoenix Medical Devices, Llp · 2012
- Descendant · cites it directly · 1 of its ownK152815 Mailuokang Self-adhesive ElectrodeShenzhen Mailuokang Technology Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK181234 Self-adhesive ElectrodeDong Guan OU Kang Electronics Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView 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 | K083302 | Lifecare Electrodes | Everyway Medical Instruments Co.,Ltd | 2009 | — |
| 0 (this device) | K112312 | Theratrode | Phoenix Medical Devices, Llp | 2012 | — |
| +1 | K152815 | Mailuokang Self-adhesive Electrode | Shenzhen Mailuokang Technology Co., Ltd. | 2016 | — |
| +2 | K181234 | Self-adhesive Electrode | Dong Guan OU Kang Electronics Co., Ltd. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K083302 | Lifecare ElectrodesSummary page 2…Code: 882.1320 / GXY 3. Legally Marketed Device to Which Equivalence is Claimed Marketed Device #1 Proprietary Name: Lifecare Electrodes, K083302 Common/Usual Name: Lifecare Neurostimulation Electrodes Classification Names: Electrode, Cutaneous Classification… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152815 | Mailuokang Self-adhesive Electrode | 2016 | 1 |
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 2.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K152815 (Shenzhen Mailuokang Technology Co., Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K083302.
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?
To conduct electrical stimulation from common varieties of electrical stimulators to the patients skin.
Single patient use - re-usable.
Self adhering and re-positionable.
Over the counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112312: Theratrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112312
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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