510(k) · Cleared
ClearedCutaneous Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhythmlink International, LLC · GXY Electrode, Cutaneous
Cleared on Aug 23, 2005 as substantially equivalent to K941799 (Bio-Logic Systems Corp., 1995) after a 12-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Aug 23, 2005
- Review
- 12 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941799 (1995). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK941799 Disposable Cutaneous ElectrodesBio-Logic Systems Corp. · 1995
- This deviceK052188 Cutaneous ElectrodeRhythmlink International, LLC · 2005
- 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 · 0 of its ownK203079 MR Conditional Sticky Pad ElectrodeRhythmlink International, LLC · 2021
- 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
Most influential descendants
Showing 5 of 5 · 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
- K203079MR Conditional Sticky Pad ElectrodeRhythmlink International, LLC · 2021 · cites it directly0descendants
- 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 | K941799 | Disposable Cutaneous Electrodes | Bio-Logic Systems Corp. | 1995 | — |
| 0 (this device) | K052188 | Cutaneous Electrode | Rhythmlink International, LLC | 2005 | — |
| +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 | K203079 | MR Conditional Sticky Pad Electrode | Rhythmlink International, LLC | 2021 | — |
| +3 | K172703 | Disposable Snap Electrode | Embla Systems | 2017 | — |
| +1 | K120494 | Disposable Adhesive Surface Electrode | Spes Medica Srl | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K941799 | Disposable Cutaneous ElectrodesSummary page 1…is device has not been previously submitted to the FDA. Predicate Device(s): 61o-logic Systems Corp 510(k)#: K941799 Device Description: Rhythmlink International Cutaneous Disposable Electrodes are single patient use, disposable devices. Elect… | 1995 |
What descends from it? (5)
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?
The Rhythmlink International Cutaneous Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating /recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only. These devices are restricted to sale by or on the order of a practitioner licensed by the Law of the State in which he/she practices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052188: Cutaneous Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052188
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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