510(k) · Cleared

Cleared

Adhesive Electrodes

K132588510(k) TraditionalCleared Nov 22, 201395-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

Top-Rank Health Care Equipment Co., Ltd. · GXY Electrode, Cutaneous

Cleared on Nov 22, 2013 as substantially equivalent to K070612 (Top-Rank Health Care Equipment Co., Ltd., 2007) after a 95-day review. Its family tree reaches back 1 generation to 2007. 6 later devices descend from it.

Decided: Nov 22, 2013
Review: 95 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K070612 (2007). 6 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK070612 Top-Rank Adhesive ElectrodeTop-Rank Health Care Equipment Co., Ltd. · 2007
This deviceK132588 Adhesive ElectrodesTop-Rank Health Care Equipment Co., Ltd. · 2013
Descendant · cites it directly · 3 of its ownK160081 TENS ElectrodesCathay Manufacturing Corp. · 2016
Descendant · 2 generations on · 0 of its ownK210448 Adhesive ElectrodeShaoxing Yingtuo Healthcare Co., Ltd. · 2021
Descendant · 2 generations on · 0 of its ownK180773 Reusable and Self-Adhesive ElectrodesShaoxing Dongzhi Electrical Technology Co., Ltd. · 2018
Descendant · 2 generations on · 0 of its ownK171722 Electrodes with snap / Electrodes with pigtailShenzhen Konmed Technology Co., Ltd. · 2018
Descendant · cites it directly · 0 of its ownK170744 Adhesive ElectrodesReno Medical, Ltd. · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014high 2 (2018) · low 0 (2015)2026

Most influential descendants

Showing 5 of 6 · See all

K160081TENS ElectrodesCathay Manufacturing Corp. · 2016 · cites it directly3descendants
K210448Adhesive ElectrodeShaoxing Yingtuo Healthcare Co., Ltd. · 2021 · 2 generations on0descendants
K180773Reusable and Self-Adhesive ElectrodesShaoxing Dongzhi Electrical Technology Co., Ltd. · 2018 · 2 generations on0descendants
K171722Electrodes with snap / Electrodes with pigtailShenzhen Konmed Technology Co., Ltd. · 2018 · 2 generations on0descendants
K170744Adhesive ElectrodesReno Medical, Ltd. · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K070612	Top-Rank Adhesive Electrode	Top-Rank Health Care Equipment Co., Ltd.	2007	—
0 (this device)	K132588	Adhesive Electrodes	Top-Rank Health Care Equipment Co., Ltd.	2013	—
+1	K160081	TENS Electrodes	Cathay Manufacturing Corp.	2016	—
+2	K210448	Adhesive Electrode	Shaoxing Yingtuo Healthcare Co., Ltd.	2021	—
+2	K180773	Reusable and Self-Adhesive Electrodes	Shaoxing Dongzhi Electrical Technology Co., Ltd.	2018	—
+2	K171722	Electrodes with snap / Electrodes with pigtail	Shenzhen Konmed Technology Co., Ltd.	2018	—
+1	K170744	Adhesive Electrodes	Reno Medical, Ltd.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2016	1	0
2017	1	0
2018	2	0
2021	1	0

FIG. 1 — Lineage of K132588, 2007–2021Source: 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
*	K070612	Top-Rank Adhesive Electrode Summary page 2 …nscutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use. 5. Predicate Device Identification 510(k) Number: K070612 Product Name: Top-Rank Adhesive Electrodes Mlanufacturer: Pop-Rank Health Care Co.. Ltd. 6. lDevice lDescription…	Top-Rank Health Care Equipment Co., Ltd.	2007	—

Also cleared against K070612: 2 other devices →

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K160081	TENS Electrodes	Cathay Manufacturing Corp.	2016	3
K170744	Adhesive Electrodes	Reno Medical, Ltd.	2017	0
K131720	Hivox Self Adhesive Electrode Gel Pads	Hivox Biotek, Inc.	2014	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?

Its one ancestor has no recall.
Of its descendants, K160081 (Cathay Manufacturing Corp., 2016) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K070612.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?

Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132588 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132588: Adhesive Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132588

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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