# K083287: Avivo Mobile Patient Management System

- Pathway: 510(k) (Abbreviated)
- Applicant: Corventis, Inc.
- Decided: Feb 3, 2009 after 88 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 5 generations back to K882803 (1988). 10 ancestors in all.
57 later devices descend from it; 6 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072558: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005, Cardionet, Inc. (2007) Summary page 1.
- K043604: Lifeshirt Real-Time with Vivomonitor Software, Vivometrics, Inc. (2005) Summary page 1.
- K042113: Zoe Fluid Status Monitor, Noninvasive Medical Technologies, LLC (2004) Summary page 1.
- (no number) SenseWear Armband: named in the summary without a submission number

## Most influential descendants
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System (2009), 40 descendants of its own
- K091971: Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System (2009), 38 descendants of its own
- K111917: Nuvant, Mobile Cardiac Telemetry (2011), 30 descendants of its own
- K113372: Nuvant, Mobilc Cardiac Telemetry (2012), 24 descendants of its own
- K133701: Nuvant MCT System (2014), 23 descendants of its own

## Indications for use
The AVIVOTM Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVOTM Mobile Patient Management System also monitors, derives and, displays: *ECG - Heart Rate (including Heart Rate Variability) - Activity - Posture * Body Temperature · Respiration rate (including Respiratory Rate Variability) · Body fluid status

Source page: https://510kreport.com/device/K083287
Methodology: https://510kreport.com/methodology