# K200833: RX-1 Rhythm Express Remote Cardiac Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: VivaQuant, Inc.
- Decided: Sep 2, 2020 after 156 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K882803 (1988). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183704: RX-1 Rhythm Express Remote Cardiac Monitoring System, VivaQuant, Inc. (2019) Summary page 4.
- K152550: Medicalgorithmics Unified Arrhythmia Diagnosic System, Medicalgorithmics S.A. (2015) Summary page 4.

## Most influential descendants
- K241179: Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) (2025), 0 descendants of its own

## Indications for use
The Rhythm Express remote cardiac monitoring system is intended for use by patients greater than 10 kg who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented for review by a medical professional. The data received from the Rhythm Express device can be used by another device for arrhythmia analysis, reporting and signal measurements. The Rhythm Express device is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. The Rhythm Express system communicates events from the patient to the monitoring center within one to seven minutes (assuming cell service is available) and hence is not suitable for use as a real-time arrhythmia event monitor.

Source page: https://510kreport.com/device/K200833
Methodology: https://510kreport.com/methodology