510(k) · Cleared

Cleared

Lifecare 55 CM Square, Lifecare 44 CM Square, Lifecare 5 CM Round, Lifecare 7.5 CM Round, Lifecare 4*6 CM Oval

K012463510(k) TraditionalCleared Feb 5, 2002188-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

Everyway Medical Instruments Co.,Ltd · GXY Electrode, Cutaneous

Cleared on Feb 5, 2002 after a 188-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 41 later devices descend from it.

Decided: Feb 5, 2002
Review: 188 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 0

41 later devices descend from it, 2 citing it directly.

This deviceK012463 Lifecare 5*5 CM Square, Lifecare 4*4 CM Square, Lifecare 5 CM Round…Everyway Medical Instruments Co.,Ltd · 2002
Descendant · cites it directly · 40 of its ownK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
Descendant · 2 generations on · 22 of its ownK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
Descendant · 3 generations on · 21 of its ownK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
Descendant · 2 generations on · 16 of its ownK092546 Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM…Gmdasz Manufacturing Co., Ltd. · 2009
Descendant · 3 generations on · 15 of its ownK160138 Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2005high 5 (2023) · low 0 (2006)2026

Most influential descendants

Showing 5 of 41 · See all

K050469EZ-Stik ElectrodesNaimco, Inc. · 2005 · cites it directly40descendants
K052875Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005 · 2 generations on22descendants
K062675Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double…Gemore Technology Co, Ltd. · 2007 · 3 generations on21descendants
K092546Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM, CWN1007.Dia. 7CM…Gmdasz Manufacturing Co., Ltd. · 2009 · 2 generations on16descendants
K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016 · 3 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K012463	Lifecare 55 CM Square, Lifecare 44 CM Square, Lifecare 5 CM Round, Lifecare…	Everyway Medical Instruments Co.,Ltd	2002	—
+1	K050469	EZ-Stik Electrodes	Naimco, Inc.	2005	4
+2	K052875	Prostim Reusable Neurostimulation Electrodes	Summit Manufacturing, LLC	2005	—
+3	K062675	Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and…	Gemore Technology Co, Ltd.	2007	—
+2	K092546	Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM…	Gmdasz Manufacturing Co., Ltd.	2009	—
+3	K160138	Adhesive Electrodes	Gmdasz Manufacturing Co., Ltd.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2007	1	0
2009	3	0
2012	2	0
2013	1	0
2014	3	0
2015	4	0
2016	3	0
2017	1	0
2018	2	0
2019	3	0
2021	1	0
2022	2	0
2023	5	0
2024	2	0
2025	5	0
2026	1	0

FIG. 1 — Lineage of K012463, 2002–2026Source: 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
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

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

What descends from it? (41)

See all 41

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

Number	Device	Applicant	Decided	Descendants
K050469	EZ-Stik Electrodes	Naimco, Inc.	2005	40
K083302	Lifecare Electrodes	Everyway Medical Instruments Co.,Ltd	2009	14

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, K050469 (Naimco, Inc., 2005) has gone furthest, with 40 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.

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 Lifecare electrodes are intended to be used with transcutaneous neurostimulation devices. Some common types of neurostimulation devices include, but are not limited to, TENS devices and powered muscle stimulation devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patinet's skin and a neurostimulation device.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012463 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012463: Lifecare 5*5 CM Square, Lifecare 4*4 CM Square, Lifecare 5 CM Round, Lifecare 7.5 CM Round, Lifecare 4*6 CM Oval.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012463

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026

Lifecare 5*5 CM Square, Lifecare 4*4 CM Square, Lifecare 5 CM Round, Lifecare 7.5 CM Round, Lifecare 4*6 CM Oval