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 Dec 1, 2017 as substantially equivalent to K130287 (Rhythmlink International, LLC, 2013) after a 105-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 1, 2017
- Review
- 105 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942921 (1995). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK942921 Neurolink Eeg/EP/Emg Surface ElectrodesNeuro Supplies, Inc. · 1995
- 2 generations backK061148 Rhythmlink Disc ElectrodesRhythmlink International, LLC · 2006
- 1 generation backK130287 MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC · 2013
- This deviceK172503 MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC · 2017
- Descendant · cites it directly · 2 of its ownK242346 Grass® MR Conditional/CT Cup ElectrodesNatus Manufacturing Limited · 2024
- Descendant · 2 generations on · 0 of its ownK260578 Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US…Ambu A/S · 2026
- Descendant · 2 generations on · 0 of its ownK254183 MR Conditional Cup ElectrodesTechnomed Europe · 2026
Most influential descendants
Showing 3 of 3 · See all- K242346Grass® MR Conditional/CT Cup ElectrodesNatus Manufacturing Limited · 2024 · cites it directly2descendants
- K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US)…Ambu A/S · 2026 · 2 generations on0descendants
- K254183MR Conditional Cup ElectrodesTechnomed Europe · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942921 | Neurolink Eeg/EP/Emg Surface Electrodes | Neuro Supplies, Inc. | 1995 | — |
| −2 | K061148 | Rhythmlink Disc Electrodes | Rhythmlink International, LLC | 2006 | — |
| −1 | K130287 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | Rhythmlink International, LLC | 2013 | — |
| 0 (this device) | K172503 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | Rhythmlink International, LLC | 2017 | — |
| +1 | K242346 | Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited | 2024 | — |
| +2 | K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US… | Ambu A/S | 2026 | — |
| +2 | K254183 | MR Conditional Cup Electrodes | Technomed Europe | 2026 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K130287 | MR Conditional Cup Electrode, MR Conditional Webb ElectrodeSummary page 4…GXY Classification: 21 CFR 882.1320 Class II Classification Panel: Neurology 807.92(a)(3) K130287 - MR Conditional Cup and Webb Electrode Predicate Device 807.92(a)(4) The fundamental scientific technology of Rhythmlink… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242346 | Grass® MR Conditional/CT Cup Electrodes | 2024 | 2 |
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 2 companies; a new generation was cleared every 7.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K242346 (Natus Manufacturing Limited, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K130287.
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 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/K172503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172503: 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 6, 2026. https://510kreport.com/device/K172503
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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