510(k) · Cleared
ClearedRhythmlink Disc Electrodes
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 10, 2006 as substantially equivalent to K942921 (Neuro Supplies, Inc., 1995) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1995. 50 later devices descend from it.
- Decided
- May 10, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942921 (1995). 2 ancestors in all. 50 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK942921 Neurolink Eeg/EP/Emg Surface ElectrodesNeuro Supplies, Inc. · 1995
- This deviceK061148 Rhythmlink Disc ElectrodesRhythmlink International, LLC · 2006
- Descendant · cites it directly · 35 of its ownK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- Descendant · 2 generations on · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- Descendant · 3 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- Descendant · 4 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- Descendant · 5 generations on · 22 of its ownK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K112718Nuvasive NVM5 SystemNuvasive, Inc. · 2012 · cites it directly35descendants
- K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · 2 generations on33descendants
- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 3 generations on24descendants
- K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 4 generations on23descendants
- K143641NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · 5 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942921 | Neurolink Eeg/EP/Emg Surface Electrodes | Neuro Supplies, Inc. | 1995 | — |
| 0 (this device) | K061148 | Rhythmlink Disc Electrodes | Rhythmlink International, LLC | 2006 | — |
| +1 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| +2 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| +3 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| +4 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| +5 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K942921 | Neurolink Eeg/EP/Emg Surface ElectrodesSummary page 1…Product Code: GXY This device has not been previously submitted to the FDA. Predicate Device(s): Neurolink TM 510(k) Number: K942921 Neuro Supplies 510(k) Number: K991772! Device Description: Rhythmlink Disc Electrodes are non-inva… | 1995 |
| * | K991772 | Cutaneous (Disc) ElectrodeSummary page 1…ce has not been previously submitted to the FDA. Predicate Device(s): Neurolink TM 510(k) Number: K942921 Neuro Supplies 510(k) Number: K991772! Device Description: Rhythmlink Disc Electrodes are non-invasive, Cutaneous devices are used in the acquisition of signals f… | 1999 |
What descends from it? (50)
See all 506 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112718 | Nuvasive NVM5 System | 2012 | 35 |
| K072016 | Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride… | 2007 | 6 |
| K130287 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | 2013 | 5 |
| K170138 | Neuronaute | 2017 | 0 |
| K123915 | DE48-Plus | 2013 | 0 |
| K112717 | Nuvasive Nvjjb System | 2012 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K112718 (Nuvasive, Inc., 2012) has gone furthest, with 35 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.
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 Rhythmlink Disc Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061148 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061148: Rhythmlink Disc Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061148
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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