510(k) · Cleared

Cleared

Reusable Stimulating Electrodes

K111270510(k) TraditionalCleared Sep 13, 2011133-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

Bio Protech, Inc. · GXY Electrode, Cutaneous

Cleared on Sep 13, 2011 after a 133-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Sep 13, 2011
Review: 133 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK111270 Reusable Stimulating ElectrodesBio Protech, Inc. · 2011
Descendant · cites it directly · 0 of its ownK161282 FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S…Medico Electrodes International, Ltd. · 2016

Most influential descendants

Showing 1 of 1 · See all

K161282FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S…Medico Electrodes International, Ltd. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K111270, 2011–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K161282	FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S…	Medico Electrodes International, Ltd.	2016	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?

Of its descendants, K161282 (Medico Electrodes International, Ltd., 2016) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?

Blo Protech Reusable Stimulating electrodes are intended to be used to apply electrical stimulation current to the patient's skin or to record physiological signals.

Electrical stimulation current applications of these electrodes are:

a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief.

b) Electrical muscle stimulation (EMS)

c) Functional electrical stimulation (FES)

d) Microcurrent electrical nerve stimulation (MENS)

e) Interferential stimulation (IF)

f) Neuromuscular electrical stimulation (NMES)

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K111270 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111270: Reusable Stimulating Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111270

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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