# K050248: Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Electramold
- Decided: May 25, 2005 after 111 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The ECG electrode is intended to monitor patients. The electrode monitors and relates body functions through a monitoring device, The electrode senses functions in the body, gathers information, and relates that information to the device with which it is connected. The information gathered by the electrode can then be assessed by medical personnel in order to aid in determining the proper medical coursetf action,

Source page: https://510kreport.com/device/K050248
Methodology: https://510kreport.com/methodology