# K091971: Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System

- Pathway: 510(k) (Special)
- Applicant: Corventis, Inc.
- Decided: Aug 27, 2009 after 57 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: 7 generations back to K882803 (1988). 21 ancestors in all.
38 later devices descend from it; 3 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083287: Avivo Mobile Patient Management System, Corventis, Inc. (2009) Summary page 1.
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System, Corventis, Inc. (2009). Our reading of the summary gave K090606, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NUVANT Mobile Cardiac Telemetry System”. Summary page 2.
- K071130: Heartrak AF, Universal Medical, Inc. (2008) Summary page 1.
- K072558: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005, Cardionet, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K163512: Zio AT ECG Monitoring System (2017), 18 descendants of its own
- K181502: Zio AT ECG Monitoring System, ZEUS System (2018), 12 descendants of its own

## Indications for use
The AVIVO™ 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 AVIVO Mobile Patient Management System also monitors, derives and displays: ECG Heart Rate (including HR variability) Activity Posture Body Temperature Respiration rate (including RR variability) Body fluid status The NUVANT TM Mobile Cardiac Telemetry (NUVANT) System is intended to continuously measure, record, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The NUVANT system model monitors, derives and displays: * EGG * Heart rate The Systems may also monitor, derive and display: * Activity * Posture * Respiration rate (including RR Variability) * Body fluid status * Heart rate variability

Source page: https://510kreport.com/device/K091971
Methodology: https://510kreport.com/methodology