# K100418: Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Sep 3, 2010 after 199 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902195 (1990). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083350: Tens/Nmes/Fes Stimulating Electrode, Covidien LP (2009) Summary page 2.
- K902195: TBD Tens Reusable Electrode, Empi (1990) Summary page 1.

## Most influential descendants
- K182111: DL Self-adhesive Electrode (2019), 3 descendants of its own
- K241512: Electrode Pad (2025), 1 descendant of its own
- K253237: Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) (2026), 0 descendants of its own
- K183154: SM Electrodes (2019), 0 descendants of its own

## Indications for use
The Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is indicated for use with transcutaneous electrical stimulation devices to provide the conductive interface between the stimulation device and the patient's skin.

Source page: https://510kreport.com/device/K100418
Methodology: https://510kreport.com/methodology