# K052188: Cutaneous Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Aug 23, 2005 after 12 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 K941799 (1995). 1 ancestor in all.
5 later devices descend from it; 3 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)
- K941799: Disposable Cutaneous Electrodes, Bio-Logic Systems Corp. (1995) Summary page 1.

## Most influential descendants
- K110289: Friendship Medical Disposable Pre-Gelled AG / Agcl Surface Electrode (2011), 2 descendants of its own
- K142159: Disposable Pre-Gelled Surface Electrode (2015), 1 descendant of its own
- K203079: MR Conditional Sticky Pad Electrode (2021), 0 descendants of its own
- K172703: Disposable Snap Electrode (2017), 0 descendants of its own
- K120494: Disposable Adhesive Surface Electrode (2012), 0 descendants of its own

## Indications for use
The Rhythmlink International Cutaneous Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating /recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only. These devices are restricted to sale by or on the order of a practitioner licensed by the Law of the State in which he/she practices.

Source page: https://510kreport.com/device/K052188
Methodology: https://510kreport.com/methodology