# K153160: AVIVO Mobile Patient Management (MPM) System

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Mar 30, 2016 after 149 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). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 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.
- K113372: Nuvant, Mobilc Cardiac Telemetry, Corventis, Inc. (2012) Summary page 4.
- K133701: Nuvant MCT System, Corventis, Inc. (2014) Summary page 4.

## Indications for use
The AVIVO™ Mobile Patient Management (MPM) System is intended to continuously measure, record and periodically transmit physiological data. The AVIVO™ MPM System is indicated for patients: • With fluid management problems • Taking diuretic medication • Living with heart failure • Living with end-stage renal disease • Suffering from recurrent dehydration • Who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The AVIVO™ MPM System monitors, derives and displays: • ECG • Heart Rate (including HR variability) • Activity • Posture • Respiration Rate (including RR variability) • Body Fluid Status The system has not been tested specifically for pediatric use.

Source page: https://510kreport.com/device/K153160
Methodology: https://510kreport.com/methodology