510(k) · Cleared
ClearedDisposable Pre-Gelled Surface Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rochester Electro Medical, Inc. · GXY Electrode, Cutaneous
Cleared on Jun 3, 2015 as substantially equivalent to K110289 (Xian Friendship Medical Electronics Co., Ltd., 2011) after a 301-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Jun 3, 2015
- Review
- 301 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941799 (1995). 6 ancestors in all, the oldest K821137 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK941799 Disposable Cutaneous ElectrodesBio-Logic Systems Corp. · 1995
- 2 generations backK052188 Cutaneous ElectrodeRhythmlink International, LLC · 2005
- 1 generation backK110289 Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeXian Friendship Medical Electronics Co., Ltd. · 2011
- This deviceK142159 Disposable Pre-Gelled Surface ElectrodeRochester Electro Medical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK172703 Disposable Snap ElectrodeEmbla Systems · 2017
Most influential descendants
Showing 1 of 1 · See all- K172703Disposable Snap ElectrodeEmbla Systems · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941799 | Disposable Cutaneous Electrodes | Bio-Logic Systems Corp. | 1995 | — |
| −2 | 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 | — |
| 0 (this device) | K142159 | Disposable Pre-Gelled Surface Electrode | Rochester Electro Medical, Inc. | 2015 | — |
| +1 | K172703 | Disposable Snap Electrode | Embla Systems | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K110289 | Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeSummary page 4…trode, Class II (performance standards) Product Code: GXY Equivalence / Predicate Device: Friendship Pre-gelled Ag/AgCl Surface Electrodes, 510(k) Number K110289 Description: A conductive solid gel electrode consisting of a conductive adhesive gel, a silver… | 2011 |
| † | K010431 | Lead-Lok Reusable Tens/ Nmes Electrodes | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172703 | Disposable Snap Electrode | 2017 | 0 |
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 20 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K172703 (Embla Systems, 2017) has gone furthest, with 0 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. 2015, 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 Disposable Pre-gelled Surface Electrodes are intended for recording/stimulation and monitoring of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potential (EP) signals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142159 · printed Nov 3, 2026
Cite this page
510(k) Report. “K142159: Disposable Pre-Gelled Surface Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K142159
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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