510(k) · Cleared
ClearedSunspots Pre-Gelled Surface Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axon Systems, Inc. · GXY Electrode, Cutaneous
Cleared on Dec 19, 2006 as substantially equivalent to K971914 (Medelec, Inc. D.B.A. Teca Corp., 1998) and 1 other predicate after a 140-day review. Its family tree reaches back 1 generation to 1982. 6 later devices descend from it.
- Decided
- Dec 19, 2006
- Review
- 140 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K821137 (1982). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK821137 Meditrace Pellet ElectrodeGraphic Controls Corp. · 1982
- This deviceK062198 Sunspots Pre-Gelled Surface ElectrodesAxon Systems, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK110289 Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeXian Friendship Medical Electronics Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK142159 Disposable Pre-Gelled Surface ElectrodeRochester Electro Medical, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK081871 Universal ElectrodesNeurometrix, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK172703 Disposable Snap ElectrodeEmbla Systems · 2017
- Descendant · cites it directly · 0 of its ownK120494 Disposable Adhesive Surface ElectrodeSpes Medica Srl · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110289Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeXian Friendship Medical Electronics Co., Ltd. · 2011 · cites it directly2descendants
- K142159Disposable Pre-Gelled Surface ElectrodeRochester Electro Medical, Inc. · 2015 · 2 generations on1descendant
- K081871Universal ElectrodesNeurometrix, Inc. · 2008 · cites it directly1descendant
- K172703Disposable Snap ElectrodeEmbla Systems · 2017 · 3 generations on0descendants
- K120494Disposable Adhesive Surface ElectrodeSpes Medica Srl · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821137 | Meditrace Pellet Electrode | Graphic Controls Corp. | 1982 | — |
| 0 (this device) | K062198 | Sunspots Pre-Gelled Surface Electrodes | Axon Systems, Inc. | 2006 | — |
| +1 | K110289 | Friendship Medical Disposable Pre-Gelled AG / Agcl Surface Electrode | Xian Friendship Medical Electronics Co., Ltd. | 2011 | — |
| +2 | K142159 | Disposable Pre-Gelled Surface Electrode | Rochester Electro Medical, Inc. | 2015 | — |
| +1 | K081871 | Universal Electrodes | Neurometrix, Inc. | 2008 | — |
| +3 | K172703 | Disposable Snap Electrode | Embla Systems | 2017 | — |
| +1 | K120494 | Disposable Adhesive Surface Electrode | Spes Medica Srl | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971914 | Teca NCS Electrode System 2000Summary page 1…ct Codes: GXZ Predicate Manufacturer: Nicolet Biomedical Devices: Trade Name: Pre-gelled Surface Electrodes FDA number: K971914 Manufacturer: Medicotest, Inc. Trade Name: Surface Electrodes FDA… | 1998 |
| Kept off the family tree | K931030 | Surface Electrodes Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…FDA number: K971914 Manufacturer: Medicotest, Inc. Trade Name: Surface Electrodes FDA number: K931030 Manufacturer: Tyco Health Kendall (Graphic Controls) Trade Name: Medi-Trace 133 ECG Pel… | |
| * | K821137 | Meditrace Pellet ElectrodeSummary page 1…Manufacturer: Tyco Health Kendall (Graphic Controls) Trade Name: Medi-Trace 133 ECG Pellet Electrodes FDA number: K821137 Description: Electrodes are the interface medium between neurodiagnostic or neuromonitoring equipmen… | 1982 |
What descends from it? (6)
3 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?
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 | — |
What is it indicated for?
Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062198: Sunspots Pre-Gelled Surface Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062198
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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