510(k) · Cleared

Cleared

Guardian Disposable Tens and Tens/Nmes Electrodes

K945676510(k) TraditionalCleared Jan 30, 199573-day reviewClass II21 CFR 882.5890

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Selectivemed Components, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Jan 30, 1995 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 45 later devices descend from it.

Decided: Jan 30, 1995
Review: 73 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 0

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

This deviceK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
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 45 descendants. See all descendants

Descendants cleared per year

2005high 5 (2023) · low 0 (2006)2026

Most influential descendants

Showing 5 of 45 · 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)	K945676	Guardian Disposable Tens and Tens/Nmes Electrodes	Selectivemed Components, Inc.	1995	—
+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	4	0
2012	3	0
2013	2	0
2014	3	0
2015	4	0
2016	3	0
2017	1	0
2018	3	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 K945676, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GZJ? 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 GZJ device

#1 K252767 actiTENS miniscore 13.1 · 9 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (45)

See all 45

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
K083756	Guardian 150 Electrode	Selectivemed Components, Inc.	2009	3

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 GZJ devices

GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZJ

1in 2025

2007high 16 (2009) · low 1 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZJ

207in 2024

2007high 344 (2014) · low 113 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GZJ

1in 2011

2007high 4 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GZJ

13in 2025

2007high 58 (2017) · low 4 (2007)2025

MAUDE reports naming product code GZJ, 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	13	223	4	4
2008	11	136	1	45
2009	16	155	0	17
2010	5	232	0	22
2011	5	168	1	22
2012	12	154	0	20
2013	2	—	0	10
2014	4	344	0	23
2015	3	202	0	18
2016	3	163	0	32
2017	3	113	0	58
2018	2	—	0	21
2019	3	156	0	7
2020	4	183	0	10
2021	3	231	0	5
2022	4	175	0	4
2023	1	—	0	39
2024	3	207	0	12
2025	1	—	0	13
2026	2	—	0	—

https://510kreport.com/device/K945676 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945676: Guardian Disposable Tens and Tens/Nmes Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945676

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026