# K162956: Nowcardio System

- Pathway: 510(k) (Abbreviated)
- Applicant: Contex International Technologies (Canada), Inc.
- Decided: Sep 22, 2017 after 333 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: 11 generations back to K882803 (1988). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133701: Nuvant MCT System, Corventis, Inc. (2014) Summary page 5.
- K121197: Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect, Preventice, Inc. (2012) Summary page 5.

## Most influential descendants
- K182532: Liba3 System (2019), 0 descendants of its own

## Indications for use
The NowCardio™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified healthcare professional for out-patient individuals with known non-lethal arrhythmias such as: • Atrial Fibrillation • Bradycardia • Tachycardia • Pause It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the NowCardio™ will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG data are available to HealthCare Providers for analysis and reporting. NowCardio™ is intended to be used with adult patients 22 years and older, but not designed for pediatric patients.

Source page: https://510kreport.com/device/K162956
Methodology: https://510kreport.com/methodology