# K233409: Eko Low Ejection Fraction Tool (ELEFT)

- Pathway: 510(k) (Traditional)
- Applicant: Eko Health, Inc.
- Decided: Mar 28, 2024 after 174 days
- Product code: QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software)
- Device class: 2
- Regulation: 21 CFR 870.2380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN230003 (2023). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232699: Low Ejection Fraction AI-ECG Algorithm, Anumana, Inc. (2023) Summary page 5.

## Indications for use
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity. The interpretations of heart sounds and ECG offered by the software are meant only to assist healthcare providers in assessing Left Ventricular Ejection Fraction ≤ 40%, who may use the result in conjunction with their own evaluation and clinical judgment. It is not a diagnosis or for monitoring of patients diagnosed with heart failure. This software is for use on adults (18 years and older).

Source page: https://510kreport.com/device/K233409
Methodology: https://510kreport.com/methodology