510(k) · Cleared
ClearedColumbia 600 Electrode, Columbia 06 Leadwire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Columbia Scientific Development, LLC · GXY Electrode, Cutaneous
Cleared on May 30, 2008 as substantially equivalent to K070807 (Pepin Mfg., Inc., 2007) after a 107-day review. Its family tree reaches back 3 generations to 1987. 4 later devices descend from it.
- Decided
- May 30, 2008
- Review
- 107 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871222 (1987). 7 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK871222 Tantone Multi-Day #633 Tens ElectrodeUni-Patch, Inc. · 1987
- 2 generations backK983097 Tens/Fes/Nmes ElectrodesUni-Patch, Inc. · 1999
- 1 generation backK070807 Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc. · 2007
- This deviceK080386 Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC · 2008
- Descendant · cites it directly · 3 of its ownK083756 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 · 2 generations on · 0 of its ownK113375 Eswallow Usa Electrode,Eswallow Usa LeadwireEswallow USA · 2013
Most influential descendants
Showing 4 of 4 · See all- K083756Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009 · cites it directly3descendants
- 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871222 | Tantone Multi-Day #633 Tens Electrode | Uni-Patch, Inc. | 1987 | — |
| −2 | K983097 | Tens/Fes/Nmes Electrodes | Uni-Patch, Inc. | 1999 | — |
| −1 | K070807 | Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes | Pepin Mfg., Inc. | 2007 | — |
| 0 (this device) | K080386 | Columbia 600 Electrode, Columbia 06 Leadwire | Columbia Scientific Development, LLC | 2008 | — |
| +1 | 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 | — |
| +2 | 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 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K070807 | Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesSummary page 1…new device. Classification Name: 21 CFR 882.1320 21 CFR 898.12 Classification Panel: Neurology Predicate Device(s): 510O(K) Number: K070807, Product Code: GXY Applicant: Pepin Manufacturing Inc. Trade Name: PMI Cutaneous Ele… | 2007 |
What descends from it? (4)
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 21 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K083756 (Selectivemed Components, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K070807.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Columbia Scientific, Inc. cutaneous electrotherapy and recording electrodes are
intended to be used to apply electrical stimulation current to the patient's skin or
record physiological signals.
Example electrical stimulation current applications of these electrodes are:
a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief.
b) Electrical muscle stimulation (EMS) for neck muscle stimulation
c) Functional electrical stimulation (FES).
d) Galvanic stimulation.
e) Microcurrent electrical nerve stimulation (MENS).
f) Interferential stimulation.
g) Neuromuscular electrical stimulation (NMES).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080386: Columbia 600 Electrode, Columbia 06 Leadwire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080386
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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