510(k) · Cleared
ClearedTempus ECG-Low EF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tempus AI, Inc. · QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
Cleared on Jul 15, 2025 as substantially equivalent to K232699 (Anumana, Inc., 2023) after a 180-day review. Its family tree reaches back 2 generations to 2023.
- Decided
- Jul 15, 2025
- Review
- 180 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 19.1 · 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…QYE Predicate Device: Anumana, Inc. Low Ejection Fraction AI-ECG Algorithm Submission Number: K232699 Product Code: QYE Indications For Use Tempus ECG-Low EF is software intended to analyze re… | 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 2 years and passes through 3 companies; a new generation was cleared every 1.8 years 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. 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?
Tempus ECG-Low EF is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older at risk of heart failure. This population includes but is not limited to patients with atrial fibrillation, aortic…
Read the full statement (200 words)
Tempus ECG-Low EF is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older at risk of heart failure. This population includes but is not limited to patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease.
Tempus ECG-Low EF only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-Low EF is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history.
A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of low LVEF. Patients receiving a negative result should continue to be evaluated in accordance with current medical practice standards using all available clinical information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250119 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250119: Tempus ECG-Low EF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250119
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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