510(k) · Cleared

Cleared

MR Conditional Sticky Pad Electrode

K203079510(k) TraditionalCleared Feb 9, 2021119-day reviewClass II21 CFR 882.1320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Rhythmlink International, LLC · GXY Electrode, Cutaneous

Cleared on Feb 9, 2021 as substantially equivalent to K052188 (Rhythmlink International, LLC, 2005) after a 119-day review. Its family tree reaches back 2 generations to 1995.

Decided: Feb 9, 2021
Review: 119 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K941799 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK941799 Disposable Cutaneous ElectrodesBio-Logic Systems Corp. · 1995
1 generation backK052188 Cutaneous ElectrodeRhythmlink International, LLC · 2005
This deviceK203079 MR Conditional Sticky Pad ElectrodeRhythmlink International, LLC · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K941799	Disposable Cutaneous Electrodes	Bio-Logic Systems Corp.	1995	—
−1	K052188	Cutaneous Electrode	Rhythmlink International, LLC	2005	—
0 (this device)	K203079	MR Conditional Sticky Pad Electrode	Rhythmlink International, LLC	2021	—

FIG. 1 — Lineage of K203079, 1995–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K052188	Cutaneous Electrode Summary page 4 …GXY Classification: 21 CFR 882.1320 Class II Classification Panel: Neurology 807.92(a)(3) K052188 – Rhythmlink Cutaneous Electrode Predicate Device 807.92(a)(4) The MR Conditional Sticky Pad Electrode is intended to be…	Rhythmlink International, LLC	2005	—
†	K130287	MR Conditional Cup Electrode, MR Conditional Webb Electrode	Rhythmlink International, LLC	2013	—

Also cleared against K052188: 2 other devices →

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 26 years and passes through 2 companies; a new generation was cleared every 15.5 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K052188.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · GXY

6in 2025

2007high 17 (2009) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXY

148in 2025

2007high 203 (2014) · low 81 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXY

2in 2023

2007high 5 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXY

58in 2025

2007high 58 (2025) · low 10 (2018)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 MR Conditional Sticky Pad Electrode is intended for use with recording, monitoring, and stimulation equipment in the study of biopotentials such as Electroencephalograph (EEG), Surface Electromyography (EMG), or Nerve Conduction Evoked Potential Signals (EP). This device is non-sterile, single-use only, and may remain on the patient in a MRI environment under specific conditions.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K203079 · printed Nov 5, 2026

Cite this page

510(k) Report. “K203079: MR Conditional Sticky Pad Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203079

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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