510(k) · Cleared
ClearedGuardian 150 Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Selectivemed Components, Inc. · GXY Electrode, Cutaneous
Cleared on Jun 26, 2009 as substantially equivalent to K023347 (Chattanooga Group, 2002) and 2 other predicates after a 191-day review. Its family tree reaches back 4 generations to 1987. 3 later devices descend from it.
- Decided
- Jun 26, 2009
- Review
- 191 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K871222 (1987). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK871222 Tantone Multi-Day #633 Tens ElectrodeUni-Patch, Inc. · 1987
- 3 generations backK983097 Tens/Fes/Nmes ElectrodesUni-Patch, Inc. · 1999
- 2 generations backK070807 Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc. · 2007
- 1 generation backK080386 Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC · 2008
- This deviceK083756 Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK121483 Reusable Cutaneous ElectrodeAmpcare, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK172887 XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II…Guangzhou Xinbo Electronic Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK113375 Eswallow Usa Electrode,Eswallow Usa LeadwireEswallow USA · 2013
Most influential descendants
Showing 3 of 3 · See all- K121483Reusable Cutaneous ElectrodeAmpcare, LLC · 2012 · cites it directly1descendant
- K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…Guangzhou Xinbo Electronic Co., Ltd. · 2018 · 2 generations on0descendants
- K113375Eswallow Usa Electrode,Eswallow Usa LeadwireEswallow USA · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871222 | Tantone Multi-Day #633 Tens Electrode | Uni-Patch, Inc. | 1987 | — |
| −3 | K983097 | Tens/Fes/Nmes Electrodes | Uni-Patch, Inc. | 1999 | — |
| −2 | K070807 | Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes | Pepin Mfg., Inc. | 2007 | — |
| −1 | K080386 | Columbia 600 Electrode, Columbia 06 Leadwire | Columbia Scientific Development, LLC | 2008 | — |
| 0 (this device) | K083756 | Guardian 150 Electrode | Selectivemed Components, Inc. | 2009 | — |
| +1 | K121483 | Reusable Cutaneous Electrode | Ampcare, LLC | 2012 | — |
| +2 | K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck… | Guangzhou Xinbo Electronic Co., Ltd. | 2018 | — |
| +1 | K113375 | Eswallow Usa Electrode,Eswallow Usa Leadwire | Eswallow USA | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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? (3)
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 |
|---|---|---|---|
| * | K023347 | Vital StimSummary page 1…14-Device Classification Name: Electrode, cutaneous 15-Substantial Equivalency is claimed against The electrode of the Chattanooga VitalStim, cleared under K023347 (Chattanooga group) Guardian disposable TENS and TENS/NMES electrodes cleared under K945676 (Sel… | 2002 |
| * | K945676 | Guardian Disposable Tens and Tens/Nmes ElectrodesSummary page 1…e electrode of the Chattanooga VitalStim, cleared under K023347 (Chattanooga group) Guardian disposable TENS and TENS/NMES electrodes cleared under K945676 (SelectiveMed TM Components, Inc) Columbia 600 Electrode cleared under K080386 (Columbia Scientific Develop… | 1995 |
| * | K080386 | Columbia 600 Electrode, Columbia 06 LeadwireSummary page 1…Guardian disposable TENS and TENS/NMES electrodes cleared under K945676 (SelectiveMed TM Components, Inc) Columbia 600 Electrode cleared under K080386 (Columbia Scientific Development, LLC) 16-Description of the Device: Guardian 150 electrode is a single-patient,… | 2008 |
What descends from it? (3)
2 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?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K121483 (Ampcare, LLC, 2012) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K023347.
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?
Guardian 150 electrode is indicated for use with TENS and NMES, including for Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083756 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083756: Guardian 150 Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083756
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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