# K053083: Datrix Cardio Wifi Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Datrix
- Decided: Nov 30, 2005 after 28 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002459 (2000). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013367: Cardiocollect Portable Electrocardiograph, Reynolds Medical, Ltd. (2001) Summary page 1.

## Most influential descendants
- K103427: Mobileecg System (2011), 1 descendant of its own
- K142349: TM eCloud ECG Analysis System (2015), 0 descendants of its own

## Indications for use
The Cardio WiFi Electrocardiograph is a small portable digital cardiograph intended for use by medical professionals to acquire 12-lead ECG's from single or multiple patients in a clinical or point of care setting. ECG data is first recorded to a secure digital flashcard and then transferred to an ECG management system for review by a physician or other qualified professional.

Source page: https://510kreport.com/device/K053083
Methodology: https://510kreport.com/methodology