# K092389: Disposal Ecg Electrodes, Model Easyrode

- Pathway: 510(k) (Traditional)
- Applicant: Suzuken Co., Ltd.
- Decided: Oct 13, 2009 after 69 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K070786: X-Pod Adjustable Vertebral Body Replacement, Theken Spine, LLC (2007). Our OCR of the scanned summary read K070786, FDA’s number for X-Pod Adjustable Vertebral Body Replacement (Theken Spine, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “3M Red Dot 2560 Monitoring Electrode with Foam Tape and Stickey Gel”. Kept off the family tree.

## Indications for use
The Easyrode is intended for use in ECG Monitoring. The Easyrode can be used in all ECG applications where standard ECG monitoring electrodes are used. This electrode can be used for short term and long term (2 Days) monitoring.

Source page: https://510kreport.com/device/K092389
Methodology: https://510kreport.com/methodology