510(k) · Cleared

Cleared

Rhythmlink International Subdermal Needle Electrodes

K022914510(k) TraditionalCleared Dec 20, 2002108-day reviewClass II21 CFR 882.1350

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

Rhythmlink International, LLC · GXZ Electrode, Needle

Cleared on Dec 20, 2002 as substantially equivalent to K990015 (Technomed Europe, 1999) and 1 other predicate after a 108-day review. Its family tree reaches back 3 generations to 1987. 50 later devices descend from it.

Decided: Dec 20, 2002
Review: 108 days
Class: Class II
Product code: GXZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K870795 (1987). 19 ancestors in all, the oldest K850107 (1985). 50 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 3 generations backK870795 Emg Electrodes and Extension CordsNihon Kohden America, Inc. · 1987
2 generations backK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
1 generation backK990015 Electrode NeedlesTechnomed Europe · 1999
This deviceK022914 Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002
Descendant · cites it directly · 35 of its ownK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
Descendant · 2 generations on · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
Descendant · 3 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
Descendant · 4 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
Descendant · 5 generations on · 22 of its ownK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2004high 6 (2019) · low 0 (2005)2026

Most influential descendants

Showing 5 of 50 · See all

K112718Nuvasive NVM5 SystemNuvasive, Inc. · 2012 · cites it directly35descendants
K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · 2 generations on33descendants
K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 3 generations on24descendants
K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 4 generations on23descendants
K143641NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · 5 generations on22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K870795	Emg Electrodes and Extension Cords	Nihon Kohden America, Inc.	1987	—
−2	K981004	Sle Emg Electrodes and Accessories	Specialized Laboratory Equipment, Ltd.	1998	—
−1	K990015	Electrode Needles	Technomed Europe	1999	—
0 (this device)	K022914	Rhythmlink International Subdermal Needle Electrodes	Rhythmlink International, LLC	2002	—
+1	K112718	Nuvasive NVM5 System	Nuvasive, Inc.	2012	—
+2	K123307	Nuvasive NVM5 System	Nuvasive, Inc.	2013	—
+3	K132694	Nuvasive NVM5 System	Nu Vasive, Incorporated	2014	—
+4	K141968	Nuvasive NVM5 System	Nuvasive, Inc.	2014	—
+5	K143641	NuVasive NVM5 System	Nu Vasive, Incorporated	2015	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1990	2	0
1992	2	0
1994	4	0
1995	2	0
1996	3	0
1997	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	1	0
2011	1	0
2012	2	0
2013	3	0
2014	5	0
2015	2	0
2016	3	0
2017	4	0
2018	3	0
2019	6	0
2020	1	0
2021	2	0
2022	2	0
2023	5	0
2024	3	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K022914, 1987–2026Source: 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 GXZ? 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 GXZ device

#1 K231691 Phantom XL Insulated Dilatorsscore 10.4 · 7 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
*	K990015	Electrode Needles Summary page 1 …This device has not been previously submitted to the FDA. Predicate Device(s): 5 1O(k) Number: K9900 15 Manufacturer: Technomed Europe Trade Name: Various…	Technomed Europe	1999	—
*	K010019	Sterile Subdermal Needle Electrodes	Nicolet Biomedical, Inc.	2001	1

Also cleared against K990015: 4 other devices →

What descends from it? (50)

See all 50

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

Number	Device	Applicant	Decided	Descendants
K112718	Nuvasive NVM5 System	Nuvasive, Inc.	2012	35
K072276	Subdermal Needle Electrodes	Xian Friendship Electronics Co., Ltd.	2008	5
K103103	Presson Electrode	Persyst Development Corp.	2011	2
K140200	E-Shield Multi-Paired Subdermal Needle Electrodes	Neuroinvent, Inc.	2014	1
K200984	Guardian Needle Electrode	Rhythmlink International, LLC	2020	0
K192603	Spes Medica Subdermal Needle Electrodes	Spes Medica Srl	2019	0
K112717	Nuvasive Nvjjb System	Nuvasive, Inc.	2012	0
K040639	Isurg Disposable Subdermal Needle Electrode	Isurgical	2004	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?

The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
2 of the 19 ancestors have a recall of any class.
Of its descendants, K112718 (Nuvasive, Inc., 2012) has gone furthest, with 35 descendants of its own.
4 other devices also cite its predicate K990015.

How does its category compare?

All GXZ devices

GXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXZ

1in 2024

2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXZ

102in 2007

2007high 102 (2007)2026

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

Recalls per year · GXZ

1in 2021

2007high 19 (2010) · low 0 (2007)2026

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

Adverse event reports per year · GXZ

75in 2025

2007high 75 (2025) · low 0 (2008)2025

MAUDE reports naming product code GXZ, 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	3	102	0	2
2008	2	—	0	0
2009	0	—	0	2
2010	1	—	19	4
2011	2	—	0	4
2012	1	—	0	12
2013	2	—	0	6
2014	2	—	0	8
2015	0	—	0	12
2016	1	—	0	11
2017	0	—	0	6
2018	0	—	0	9
2019	2	—	0	14
2020	1	—	0	7
2021	0	—	1	9
2022	0	—	0	18
2023	2	—	0	21
2024	1	—	0	58
2025	0	—	0	75
2026	0	—	0	—

What is it indicated for?

Rhythmlink International Subdermal Needle Electrodes are intended for use with

recording, monitoring and stimulation equipment for the purpose of recording of

biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph

(EEG) and Nerve potential signals. The electrodes are sterile and for single patient use

only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022914 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022914: Rhythmlink International Subdermal Needle Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022914

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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