# K172510: µCor Heart Failure and Arrhythmia Management System

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Manufacturing Corporation
- Decided: May 11, 2018 after 263 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K882803 (1988). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113187: Avivo Mobile Patient Management, Corventis, Inc. (2012) Summary page 4.
- K133301: Zoe Fluid Status Monitor, Noninvasive Medical Technologies, Inc. (2014) Summary page 4.

## Most influential descendants
- K190939: ZOLL Arrhythmia Management Sysyem (2019), 0 descendants of its own

## Indications for use
The µCor Heart Failure and Arrhythmia Management System is intended to periodically record, store, and transmit Thoracic Fluid Index. The µCor Heart Failure and Arrhythmia Management System is also intended to continuously record and store, and periodically transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends. The µCor Heart Failure and Arrhythmia Management System is intended for use in clinical and home settings and is indicated for patients who are 21 years of age or older: i) Who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial fibrillation, atrial flutter, ventricular ectopy, and bradyarrhythmias; or ii) Requiring fluid management.

Source page: https://510kreport.com/device/K172510
Methodology: https://510kreport.com/methodology