# K113372: Nuvant, Mobilc Cardiac Telemetry

- Pathway: 510(k) (Special)
- Applicant: Corventis, Inc.
- Decided: Mar 7, 2012 after 112 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: 9 generations back to K882803 (1988). 23 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111917: Nuvant, Mobile Cardiac Telemetry, Corventis, Inc. (2011) Summary page 5.

## Most influential descendants
- 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
- K210822: DeepRhythmAI (2022), 6 descendants of its own
- K190593: Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (2019), 4 descendants of its own

## Indications for use
The NUVANT Mobile Cardiac Telemetry (MCT) 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 such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The NUVANT system model monitors, derives and displays: * ECG * Heart Rate

Source page: https://510kreport.com/device/K113372
Methodology: https://510kreport.com/methodology