# K190416: Dome Electrode

- Pathway: 510(k) (Abbreviated)
- Applicant: Coapt, LLC
- Decided: Apr 4, 2019 after 42 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K942921 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072016: Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable, Technomed Europe (2007) Summary page 4.

## Most influential descendants
- K223605: ControlSeal Electrode (ELSB) (2022), 0 descendants of its own

## Recalls of this device
- Oct 2, 2023 · Class II · Z-0203-2024: Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

## Indications for use
The Dome Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).

Source page: https://510kreport.com/device/K190416
Methodology: https://510kreport.com/methodology