510(k) · Cleared
ClearedEko Low Ejection Fraction Tool (ELEFT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eko Health, Inc. · QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
Cleared on Mar 28, 2024 as substantially equivalent to K232699 (Anumana, Inc., 2023) after a 174-day review. Its family tree reaches back 2 generations to 2023.
- Decided
- Mar 28, 2024
- Review
- 174 days
- Class
- Class II
- Product code
- QYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN230003 (2023). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QYE device
- #1 K250652 ECG-AI Low Ejection Fraction (LEF) 12-Lead…score 19.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K232699 | Low Ejection Fraction AI-ECG AlgorithmSummary page 5…chine learning-based notification software Regulatory Class: Class II Product Code: QYE PREDICATE DEVICES ● Low Ejection Fraction AI ECG Algorithm (K232699) DEVICE DESCRIPTION Eko Low Ejection Fraction Tool (ELEFT) is an algorithm that is intended to aid clinicians to id… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 3 companies; a new generation was cleared every 6 months on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K232699.
How does its category compare?
All QYE devicesQYE Reduced Ejection Fraction Machine Learning-Based Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QYE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QYE
180in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QYE
No recall names QYE since 2007.
Adverse event reports per year · QYE
No MAUDE report names QYE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 3 | 180 | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (132 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233409: Eko Low Ejection Fraction Tool (ELEFT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233409
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026