510(k) · Cleared
ClearedDisposable Snap Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embla Systems · GXY Electrode, Cutaneous
Cleared on Nov 13, 2017 as substantially equivalent to K142159 (Rochester Electro Medical, Inc., 2015) and 1 other predicate after a 67-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Nov 13, 2017
- Review
- 67 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K941799 (1995). 8 ancestors in all, the oldest K821137 (1982). No later device cites it as a predicate yet.
- Root · 4 generations backK941799 Disposable Cutaneous ElectrodesBio-Logic Systems Corp. · 1995
- 3 generations backK052188 Cutaneous ElectrodeRhythmlink International, LLC · 2005
- 2 generations backK110289 Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeXian Friendship Medical Electronics Co., Ltd. · 2011
- 1 generation backK142159 Disposable Pre-Gelled Surface ElectrodeRochester Electro Medical, Inc. · 2015
- This deviceK172703 Disposable Snap ElectrodeEmbla Systems · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941799 | Disposable Cutaneous Electrodes | Bio-Logic Systems Corp. | 1995 | — |
| −3 | K052188 | Cutaneous Electrode | Rhythmlink International, LLC | 2005 | — |
| −2 | K110289 | Friendship Medical Disposable Pre-Gelled AG / Agcl Surface Electrode | Xian Friendship Medical Electronics Co., Ltd. | 2011 | — |
| −1 | K142159 | Disposable Pre-Gelled Surface Electrode | Rochester Electro Medical, Inc. | 2015 | — |
| 0 (this device) | 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 |
| 2003 | 1 | 0 |
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K142159 | Disposable Pre-Gelled Surface ElectrodeSummary page 4…n Name: Cutaneous Electrode Classification Name: 21 CFR 882.1320 Cutaneous Electrode Product Code: GXY Predicate Devices: K142159 Disposable Pre-gelled Surface Electrode Rochester Electro-Medical, Inc. K021537… | 2015 |
| * | K021537 | Multipurpose Neuroplus Electrode, Model A10005Summary page 4…uct Code: GXY Predicate Devices: K142159 Disposable Pre-gelled Surface Electrode Rochester Electro-Medical, Inc. K021537 Multipurpose Neuroplus Electrode Vermont Medical, Inc. Product Description The Disposable Snap Electrod… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 6.0 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Snap Electrodes are intended to be used with compatible 1.5mm touchproof button snap cables for transferring surface biopotential signals to use during sleep studies, EEG, EMG, and recording evoked potential signals from a cutaneous location. For use on Adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172703: Disposable Snap Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172703
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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