510(k) · Cleared

Cleared

Disposable Adhesive Surface Electrode

K120494510(k) TraditionalCleared Jun 11, 2012115-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

Spes Medica Srl · GXY Electrode, Cutaneous

Cleared on Jun 11, 2012 as substantially equivalent to K052188 (Rhythmlink International, LLC, 2005) and 2 other predicates after a 115-day review. Its family tree reaches back 2 generations to 1995.

Decided: Jun 11, 2012
Review: 115 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K941799 (1995). 5 ancestors in all, the oldest K821137 (1982). 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 deviceK120494 Disposable Adhesive Surface ElectrodeSpes Medica Srl · 2012

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)	K120494	Disposable Adhesive Surface Electrode	Spes Medica Srl	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1998	1	0
2006	1	0

FIG. 1 — Lineage of K120494, 1995–2012Source: 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
*	K052188	Cutaneous Electrode Summary page 1 …ce 510(k) Holder/Applicant 510(k) number RLI Cutaneous Disposable Electrode Rhythmlink International, LLC K052188 Bia-logic Disposable Electrode Blo-logic Systems Corp. K941799 Sunspots Pre-g…	Rhythmlink International, LLC	2005	—
*	K941799	Disposable Cutaneous Electrodes Summary page 1 …aneous Disposable Electrode Rhythmlink International, LLC K052188 Bia-logic Disposable Electrode Blo-logic Systems Corp. K941799 Sunspots Pre-gelled Surface Axon System, Inc. K062198 Electrodes…	Bio-Logic Systems Corp.	1995	—
*	K062198	Sunspots Pre-Gelled Surface Electrodes Summary page 1 …ic Disposable Electrode Blo-logic Systems Corp. K941799 Sunspots Pre-gelled Surface Axon System, Inc. K062198 Electrodes Section 8…	Axon Systems, Inc.	2006	—

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 17 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
None of the 5 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. 2012, 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?

Spes Medica Disposable Adhesive Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for electrical stimulation. The electrodes are non-sterile and for single patient use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120494 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120494: Disposable Adhesive Surface Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120494

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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