510(k) · Cleared
ClearedMR Conditional Cup Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technomed Europe · GXY Electrode, Cutaneous
Cleared on May 7, 2026 as substantially equivalent to K072016 (Technomed Europe, 2007) and 1 other predicate after a 135-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- May 7, 2026
- Review
- 135 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K942921 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK942921 Neurolink Eeg/EP/Emg Surface ElectrodesNeuro Supplies, Inc. · 1995
- 4 generations backK061148 Rhythmlink Disc ElectrodesRhythmlink International, LLC · 2006
- 3 generations backK130287 MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC · 2013
- 2 generations backK172503 MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC · 2017
- 1 generation backK242346 Grass® MR Conditional/CT Cup ElectrodesNatus Manufacturing Limited · 2024
- This deviceK254183 MR Conditional Cup ElectrodesTechnomed Europe · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K942921 | Neurolink Eeg/EP/Emg Surface Electrodes | Neuro Supplies, Inc. | 1995 | — |
| −4 | K061148 | Rhythmlink Disc Electrodes | Rhythmlink International, LLC | 2006 | — |
| −3 | K130287 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | Rhythmlink International, LLC | 2013 | — |
| −2 | 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 | — |
| 0 (this device) | K254183 | MR Conditional Cup Electrodes | Technomed Europe | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K072016 | Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride…Summary page 5…utaneous (21 CFR 882.1320) Regulatory Class: II Product Code: GXY 3. Predicate Device Primary Predicate: Technomed’s Cup Electrodes, K072016 2nd Predicate Device: Natus Manufacturing Ltd. Grass® MR Conditional/CT Cup Electrodes, Single and Array, K2… | 2007 |
| * | K242346 | Grass® MR Conditional/CT Cup ElectrodesSummary page 5…icate: Technomed’s Cup Electrodes, K072016 2nd Predicate Device: Natus Manufacturing Ltd. Grass® MR Conditional/CT Cup Electrodes, Single and Array, K242346 4. Device Description The MR Conditional Cup Electrodes consist of a small convex plastic (ABS) disc o… | 2024 |
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 31 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K072016.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Electrodes are intended for use in the recording of the Electroencephalogram (EEG), the Evoked Potentials (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 an MRI or CT environment under specific conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254183: MR Conditional Cup Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254183
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026