# K203079: MR Conditional Sticky Pad Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Feb 9, 2021 after 119 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: 2 generations back to K941799 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052188: Cutaneous Electrode, Rhythmlink International, LLC (2005) Summary page 4.

## Indications for use
The Rhythmlink MR Conditional Sticky Pad Electrode is intended for use with recording, monitoring, and stimulation equipment in the study of biopotentials such as Electroencephalograph (EEG), Surface Electromyography (EMG), or Nerve Conduction Evoked Potential Signals (EP). This device is non-sterile, single-use only, and may remain on the patient in a MRI environment under specific conditions.

Source page: https://510kreport.com/device/K203079
Methodology: https://510kreport.com/methodology