510(k) Report

510(k) · Cleared

Cleared

Tens/Nmes/Fes Stimulating Electrode

K083350510(k) TraditionalCleared Apr 21, 2009159-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

Covidien LP · GXY Electrode, Cutaneous

Cleared on Apr 21, 2009 after a 159-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided
Apr 21, 2009
Review
159 days
Class
Class II
Product code
GXY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2010: 1 descendant cleared2013: 1 descendant cleared2019: 2 descendants cleared2025: 1 descendant cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK083350 Tens/Nmes/Fes Stimulating ElectrodeCovidien LP · 2009
  2. Descendant · cites it directly · 4 of its ownK100418 Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating…Covidien · 2010
  3. Descendant · 2 generations on · 3 of its ownK182111 DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019
  4. Descendant · 3 generations on · 1 of its ownK241512 Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd · 2025
  5. Descendant · 4 generations on · 0 of its ownK253237 Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm…Elde Medikal Sanayi ve Ticaret Anonim Sirketi · 2026
  6. Descendant · 3 generations on · 0 of its ownK183154 SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2010: 12013: 12019: 22025: 12026: 1
2010high 2 (2019) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K100418Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating ElectrodeCovidien · 2010 · cites it directly4descendants
  • K182111DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019 · 2 generations on3descendants
  • K241512Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd · 2025 · 3 generations on1descendant
  • K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi · 2026 · 4 generations on0descendants
  • K183154SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited · 2019 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083350Tens/Nmes/Fes Stimulating ElectrodeCovidien LP2009—
+1K100418Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating ElectrodeCovidien2010—
+2K182111DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd.2019—
+3K241512Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd2025—
+4K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi2026—
+3K183154SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
201920
202510
202610
FIG. 1 — Lineage of K083350, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*—Covidien Reusable Self-adhering TENS/FES/NMES Stimulating Electrodes
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K100418Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating ElectrodeCovidien20104
K130816Interx Sterile Self-Adhesive Dual Electrode (Issde)Neuro Resource Group, Inc.20130

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, K100418 (Covidien, 2010) has gone furthest, with 4 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. 2009, this device’s year, is highlighted.

FDA decisions per year · GXY

6in 2025

2007: 72008: 92009: 172010: 32011: 62012: 92013: 72014: 92015: 62016: 62017: 92018: 142019: 92020: 42021: 122022: 52023: 132024: 72025: 62026 (partial year): 12
2007high 17 (2009) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXY

148in 2025

2007: 88 days median2008: 136 days median2009: 159 days median2010: 137 days median2011: 183 days median2012: 150 days median2013: 99 days median2014: 203 days median2015: 119 days median2016: 170 days median2017: 116 days median2018: 135 days median2019: 113 days median2020: 108 days median2021: 195 days median2022: 81 days median2023: 132 days median2024: 111 days median2025: 148 days median2026 (partial year): 70 days median
2007high 203 (2014) · low 81 (2022)2026

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

Recalls per year · GXY

2in 2023

2009: 42010: 12011: 52012: 42023: 2
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

2007: 142008: 172009: 152010: 142011: 162012: 162013: 152014: 112015: 192016: 152017: 112018: 102019: 192020: 112021: 212022: 342023: 252024: 512025: 58
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007788014
20089136017
200917159415
20103137114
20116183516
20129150416
2013799015
20149203011
20156119019
20166170015
20179116011
201814135010
20199113019
20204108011
202112195021
2022581034
202313132225
20247111051
20256148058
202612700—

What is it indicated for?

The Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes are indicated for use with transcutaneous electrical stimulation devices as non-sterile, Latex free, reusable device for single patient use only. The electrodes provide the conductive interface between the stimulation device and the patient's skin.

Indications for use as stated in the FDA summary.

More from Covidien LP

4 FDA decisions under this applicant name. See the company

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  • K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP · 2016
  • K091223Valleylab Suction Coagulator, Model E3305Covidien LP · 2009

Recent decisions in GXY

The GXY category page

  • K262664Rongjian Self-adhesive ElectrodeBozhou Rongjian Medical Appliance Co., Ltd. · 2026
  • K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd · 2026
  • K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup…Ambu A/S · 2026
  • K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc. · 2026
  • K261522BioWave BioWrapsBiowave Corporation · 2026

https://510kreport.com/device/K083350 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083350: Tens/Nmes/Fes Stimulating Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083350

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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