# K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System

- Pathway: 510(k) (Special)
- Applicant: Corventis, Inc.
- Decided: Jun 19, 2009 after 95 days
- Product code: QYX (Outpatient Cardiac Telemetry)
- 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: 6 generations back to K882803 (1988). 17 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 58 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 5.
- K042022: E-Tac EX-1000 Electrocardiographic Event Recorder, Datrix, Inc. Dba of Jon Barron, Inc. (2004) Summary page 5.
- K081365: SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator, St Jude Medical (2008) Summary page 5.
- K063222: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004, Cardionet, Inc. (2006) Summary page 5.

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

## Indications for use
The NUVANT Cardiac Event Monitor (CEM) System and the NUVANT Mobile Cardiac Telemetry (MCT) System are intended to continuously measure, record, and periodically transmit physiological data, The Systems are indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. Both NUVANT system models monitor, derive and display: ECG 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/K090696
Methodology: https://510kreport.com/methodology