510(k) · Cleared

Cleared

Ives MR Conditional Cup Electrode

K171102510(k) TraditionalCleared Dec 21, 2017252-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

Ives Egg Solutions · GXY Electrode, Cutaneous

Cleared on Dec 21, 2017 as substantially equivalent to K071118 (Ives Eeg Solutions, Inc., 2007) and 2 other predicates after a 252-day review. Its family tree reaches back 3 generations to 1995.

Decided: Dec 21, 2017
Review: 252 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K942921 (1995). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

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 deviceK171102 Ives MR Conditional Cup ElectrodeIves Egg Solutions · 2017

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)	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
2002	1	0
2004	1	0
2007	1	0
2012	1	0

FIG. 1 — Lineage of K171102, 1995–2017Source: 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? (3)

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
*	K071118	Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and… Summary page 4 …Common Name: Surface Electrode, Cutaneous electrode Classification Name: 21 CFR 882.1350, Cutaneous Electrode GXY Main Predicate 510(k) Number: K071118 Device: Manufacture: Ives EEG Solutions, LLC Trade Name: EEG Surface Ele…	Ives Eeg Solutions, Inc.	2007	—
*	K130287	MR Conditional Cup Electrode, MR Conditional Webb Electrode Summary page 4 …Trade Name: EEG Surface Electrode System Product Code: GXY Other Predicate 510(k) Number: K130287 Devices: Manufacture: Rythmlink International, LLC Trade Name: MR C…	Rhythmlink International, LLC	2013	—
*	K122376	PMT Truscan Surface Electrode Summary page 4 …MR Conditional Webb Electrode Product Code: GXY Other Predicate 510(k) Number: K122376 Devices: Manufacture: TruScan® Surface Electrodes Name: TruScan® Su…	Pmt Corp.	2012	—

Also cleared against K071118: 1 other device →

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 22 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
None of the 8 ancestors has a recall.
1 other device also cites its predicate K071118.

How does its category compare?

All GXY devices

GXY 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

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 Ives MR Conditional Cup Electrodes are intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording.

The Cup Electrodes are intended to be left in place during MR imaging at 1.5T and 3T as well as during CT scanning.

The extension cable must be disconnected from the Ives MR Conditional Cup Electrodes before scanning and MUST remain disconnected throughout the entire MR scan. EEG or EP should not be recorded throughout the entire the CT and MR imaging.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171102 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171102: Ives MR Conditional Cup Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171102

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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