510(k) · Cleared

Cleared

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W

K161282510(k) TraditionalCleared Oct 30, 2016177-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

Medico Electrodes International, Ltd. · GXY Electrode, Cutaneous

Cleared on Oct 30, 2016 as substantially equivalent to K142099 (Bio Protech, Inc., 2014) and 1 other predicate after a 177-day review. Its family tree reaches back 1 generation to 2011.

Decided: Oct 30, 2016
Review: 177 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K111270 (2011). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK111270 Reusable Stimulating ElectrodesBio Protech, Inc. · 2011
This deviceK161282 FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S…Medico Electrodes International, Ltd. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K111270	Reusable Stimulating Electrodes	Bio Protech, Inc.	2011	—
0 (this device)	K161282	FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W…	Medico Electrodes International, Ltd.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K161282, 2011–2016Source: 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? (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	Applicant	Decided	Recalls
*	K142099	Cutaneous Electrodes Summary page 4 …trodes Classification Name: Cutaneous electrode (21 CFR 882.1320) Regulatory Class: II Product Code: GXY III. PREDICATE DEVICE PROTENS Reusable Stimulating Electrodes, K142099 (Predicate Device 1) Reusable Stimulating Electrodes, K111270 (Predicate Device 2) These predicate devices had not been subject…	Bio Protech, Inc.	2014	—
*	K111270	Reusable Stimulating Electrodes Summary page 4 …20) Regulatory Class: II Product Code: GXY III. PREDICATE DEVICE PROTENS Reusable Stimulating Electrodes, K142099 (Predicate Device 1) Reusable Stimulating Electrodes, K111270 (Predicate Device 2) These predicate devices had not been subject to a design-related recall. No reference devices were used in…	Bio Protech, Inc.	2011	—

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?

None of the 2 ancestors has a recall.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?

Reusable, self-adhering neurostimulation electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161282 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161282: FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161282

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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