510(k) · Cleared
ClearedMR Conditional Cup Electrode, MR Conditional Webb 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 May 30, 2013 as substantially equivalent to K061148 (Rhythmlink International, LLC, 2006) after a 114-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- May 30, 2013
- Review
- 114 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942921 (1995). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK942921 Neurolink Eeg/EP/Emg Surface ElectrodesNeuro Supplies, Inc. · 1995
- 1 generation backK061148 Rhythmlink Disc ElectrodesRhythmlink International, LLC · 2006
- This deviceK130287 MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC · 2013
- Descendant · cites it directly · 3 of its ownK172503 MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC · 2017
- Descendant · 2 generations on · 2 of its ownK242346 Grass® MR Conditional/CT Cup ElectrodesNatus Manufacturing Limited · 2024
- Descendant · 3 generations on · 0 of its ownK260578 Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US…Ambu A/S · 2026
- Descendant · 3 generations on · 0 of its ownK254183 MR Conditional Cup ElectrodesTechnomed Europe · 2026
- Descendant · cites it directly · 0 of its ownK171102 Ives MR Conditional Cup ElectrodeIves Egg Solutions · 2017
Most influential descendants
Showing 5 of 5 · See all- K172503MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC · 2017 · cites it directly3descendants
- K242346Grass® MR Conditional/CT Cup ElectrodesNatus Manufacturing Limited · 2024 · 2 generations on2descendants
- K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US)…Ambu A/S · 2026 · 3 generations on0descendants
- K254183MR Conditional Cup ElectrodesTechnomed Europe · 2026 · 3 generations on0descendants
- K171102Ives MR Conditional Cup ElectrodeIves Egg Solutions · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942921 | Neurolink Eeg/EP/Emg Surface Electrodes | Neuro Supplies, Inc. | 1995 | — |
| −1 | K061148 | Rhythmlink Disc Electrodes | Rhythmlink International, LLC | 2006 | — |
| 0 (this device) | K130287 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | Rhythmlink International, LLC | 2013 | — |
| +1 | K172503 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | Rhythmlink International, LLC | 2017 | — |
| +2 | K242346 | Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited | 2024 | — |
| +3 | K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US… | Ambu A/S | 2026 | — |
| +3 | K254183 | MR Conditional Cup Electrodes | Technomed Europe | 2026 | — |
| +1 | K171102 | Ives MR Conditional Cup Electrode | Ives Egg Solutions | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K061148 | Rhythmlink Disc ElectrodesSummary page 1…: GXY Regulation Number: 21 CFR §882.1320, Cutaneous Electrode Regulatory Class: Class 2 807.92(a)(3) K061148 Rhythmlink Cup Electrode Predicate Device(s): Rev 2 - 5/15/2013 Page 12 ===… | 2006 |
What descends from it? (5)
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 18 years and passes through 2 companies; a new generation was cleared every 11.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K172503 (Rhythmlink International, LLC, 2017) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K061148.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 MR Conditional Cup and Webb Electrodes are intended for use in the recording of
the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and
reference in an EEG or EP recording. This device is non-sterile for Single Patient Use
Only and may remain on the patient in a MRI environment under specific conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130287 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130287: MR Conditional Cup Electrode, MR Conditional Webb Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130287
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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