# K223049: CardioSTAT® ECG Test Solution

- Pathway: 510(k) (Traditional)
- Applicant: Icentia, Inc.
- Decided: Mar 22, 2023 after 174 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: 7 generations back to K963725 (1997). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143513: ZIO SR ECG Monitoring Service, iRhythm Technologies, Inc. (2015) Summary page 4.

## Indications for use
The CardioSTAT ECG Test Solution is intended to capture, analyze, and report symptomatic and/or continuous ECG information for long-term ambulatory monitoring (up to 14 days). It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms, such as palpitations, shortness of breath, dizziness, lightheadedness, presyncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm annotation. The report does not contain diagnostic interpretation; the report is provided for review to the intended user to render a diagnosis based on clinical judgment and experience.

Source page: https://510kreport.com/device/K223049
Methodology: https://510kreport.com/methodology