# K083350: Tens/Nmes/Fes Stimulating Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Covidien LP
- Decided: Apr 21, 2009 after 159 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
No predicates in its family tree.
6 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Covidien Reusable Self-adhering TENS/FES/NMES Stimulating Electrodes: named in the summary without a submission number

## Most influential descendants
- K100418: Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode (2010), 4 descendants of its own
- 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 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.

Source page: https://510kreport.com/device/K083350
Methodology: https://510kreport.com/methodology