# K201644: QardioCore

- Pathway: 510(k) (Traditional)
- Applicant: Qardio, Inc.
- Decided: Feb 28, 2021 after 256 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K121319 (2012). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121319: Zio Patch, iRhythm Technologies, Inc. (2012) Summary page 4.

## Most influential descendants
- K240794: Frontier X Plus (2024), 0 descendants of its own

## Indications for use
The QardioCore ECG ambulatory monitoring device is intended to capture, store, transmit, and display ECG information for recording periods of up to 24-hours in a single session. It is indicated for use on adult patients who may be asymptomatic or who meet clinical indications to perform an ECG-Holter monitor exam. The QardioCore ECG monitor is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.

Source page: https://510kreport.com/device/K201644
Methodology: https://510kreport.com/methodology