510(k) · Cleared
ClearedECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anumana, Inc. · QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
Cleared on Jul 28, 2025 as substantially equivalent to K232699 (Anumana, Inc., 2023) after a 146-day review. Its family tree reaches back 2 generations to 2023. 4 later devices descend from it.
- Decided
- Jul 28, 2025
- Review
- 146 days
- Class
- Class II
- Product code
- QYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN230003 (2023). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backDEN230003 Viz HCMViz. Ai, Inc. · 2023
- 1 generation backK232699 Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. · 2023
- This deviceK250652 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK252360 ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK254302 ECG Analysis Software (AiTiALVSD)Medical AI Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK254297 Tempus ECG-MRTempus AI, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253801 ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See all- K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc. · 2026 · cites it directly1descendant
- K254302ECG Analysis Software (AiTiALVSD)Medical AI Co., Ltd. · 2026 · cites it directly0descendants
- K254297Tempus ECG-MRTempus AI, Inc. · 2026 · 2 generations on0descendants
- K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023 | — |
| −1 | K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | 2023 | — |
| 0 (this device) | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | 2025 | — |
| +1 | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | 2026 | — |
| +1 | K254302 | ECG Analysis Software (AiTiALVSD) | Medical AI Co., Ltd. | 2026 | — |
| +2 | K254297 | Tempus ECG-MR | Tempus AI, Inc. | 2026 | — |
| +1 | K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 4 | 0 |
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 K232699 Low Ejection Fraction AI-ECG Algorithmscore 18.1 · 1 generation · 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…: ECG-AI Low Ejection Fraction 12-Lead algorithm Manufacturer: Anumana, Inc. Application Number: K232699 Submission Purpose The purpose of this submission is to expand compatibility with other ECG devices from the Philips Medical Sy… | 2023 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252360 (Anumana, Inc., 2026) has gone furthest, with 1 descendant of its own.
- 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. 2025, 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?
The ECG-AI LEF 12-Lead algorithm is software intended to aid in earlier detection of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% in adults at risk for heart failure. This population includes, but is not limited to: • patients with cardiomyopathies • patients who are post-myocardial infarction • patients with aortic stenosis • patients with chronic atrial fibrillation • patients receiving pharmaceutical therapies that are…
Read the full statement (172 words)
The ECG-AI LEF 12-Lead algorithm is software intended to aid in earlier detection of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% in adults at risk for heart failure. This population includes, but is not limited to:
• patients with cardiomyopathies
• patients who are post-myocardial infarction
• patients with aortic stenosis
• patients with chronic atrial fibrillation
• patients receiving pharmaceutical therapies that are cardiotoxic, and
• postpartum women.
The ECG-AI LEF 12-Lead algorithm is not intended to be a stand-alone diagnostic device for cardiac conditions, should not be used for monitoring of patients, and should not be used on ECGs with a paced rhythm.
A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. Additionally, if the patient is at high risk for the cardiac condition, a negative result should not rule out further non-invasive evaluation.
The ECG-AI LEF 12-Lead algorithm should be applied jointly with clinician judgment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250652 · printed Nov 3, 2026
Cite this page
510(k) Report. “K250652: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K250652
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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