# K190939: ZOLL Arrhythmia Management Sysyem

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Manufacturing Corporation
- Decided: Dec 19, 2019 after 253 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: 11 generations back to K882803 (1988). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172510: µCor Heart Failure and Arrhythmia Management System, Zoll Manufacturing Corporation (2018) Summary page 4.

## Indications for use
The ZOLL Arrhythmia Management System (AMS) is intended to continuously record, store, and 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. AMS is intended for use in clinic and home settings. AMS is indicated for patients who are 21 years of age or older 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.

Source page: https://510kreport.com/device/K190939
Methodology: https://510kreport.com/methodology