510(k) · Cleared
ClearedSMD Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scientific Medical Devices, Inc. · GXY Electrode, Cutaneous
Cleared on Feb 21, 1995 after a 242-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 31 later devices descend from it.
- Decided
- Feb 21, 1995
- Review
- 242 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 2 citing it directly.
- This deviceK943009 SMD ElectrodesScientific Medical Devices, Inc. · 1995
- Descendant · cites it directly · 29 of its ownK053214 Theraknit Garment ElectrodeNeurotron Medical · 2005
- Descendant · 2 generations on · 20 of its ownK103719 Lifecare Conductive GarmentsEveryway Medical Instruments Co.,Ltd · 2011
- Descendant · 3 generations on · 19 of its ownK123354 Revitive IXActegy, Ltd. · 2013
- Descendant · 4 generations on · 17 of its ownK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
- Descendant · 5 generations on · 11 of its ownK151834 BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K053214Theraknit Garment ElectrodeNeurotron Medical · 2005 · cites it directly29descendants
- K103719Lifecare Conductive GarmentsEveryway Medical Instruments Co.,Ltd · 2011 · 2 generations on20descendants
- K123354Revitive IXActegy, Ltd. · 2013 · 3 generations on19descendants
- K143207Revitive IX (OTC)Actegy, Ltd. · 2015 · 4 generations on17descendants
- K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943009 | SMD Electrodes | Scientific Medical Devices, Inc. | 1995 | — |
| +1 | K053214 | Theraknit Garment Electrode | Neurotron Medical | 2005 | — |
| +2 | K103719 | Lifecare Conductive Garments | Everyway Medical Instruments Co.,Ltd | 2011 | — |
| +3 | K123354 | Revitive IX | Actegy, Ltd. | 2013 | — |
| +4 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| +5 | K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (31)
See all 312 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K053214 (Neurotron Medical, 2005) has gone furthest, with 29 descendants of its own.
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 | — |
https://510kreport.com/device/K943009 · printed Nov 4, 2026
Cite this page
510(k) Report. “K943009: SMD Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943009
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026