# K062760: Ori F6T Dry Ecg Monitoring Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Orbital Research, Inc.
- Decided: Dec 11, 2006 after 87 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
Longest line of descent: 3 generations back to K863116 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970796: 3M Red Dot 2560 & 2570 Monitoring Electrodes, 3M Healthcare (1997) Summary page 1.
- K043361: Accuheart Electrode Belt, Advanced Bioelectric Corporation (2005) Summary page 1.

## Indications for use
The ORI F6T Dry ECG Monitoring Electrodes are intended for use in adults (persons 18 years and older) in all ECG monitoring applications where standard ECG monitoring electrodes are used. The F6T Electrodes can be used in short term and long term (up to 2 days) ECG monitoring.

Source page: https://510kreport.com/device/K062760
Methodology: https://510kreport.com/methodology