510(k) · Cleared
ClearedBunkerhill ECG-EF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BunkerHill Health · QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
Cleared on Sep 19, 2025 as substantially equivalent to K232699 (Anumana, Inc., 2023) after a 199-day review. Its family tree reaches back 2 generations to 2023.
- Decided
- Sep 19, 2025
- Review
- 199 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…Regulatory Class II Predicate Device Proprietary Name Low Ejection Fraction AI-ECG Algorithm Premarket K232699 Notification Classification Name Cardiovascular Machine Learning-Based… | 2023 |
| † | K233409 | Eko Low Ejection Fraction Tool (ELEFT) | 2024 |
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 2.0 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?
Bunkerhill ECG-EF is software intended to aid in screening for Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% in adults at risk for, but not already diagnosed with low LVEF. Bunkerhill ECG-EF 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…
Read the full statement (153 words)
Bunkerhill ECG-EF is software intended to aid in screening for Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% in adults at risk for, but not already diagnosed with low LVEF.
Bunkerhill ECG-EF 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.
Bunkerhill ECG-EF is adjunctive and must be interpreted in conjunction with the clinician’s judgment, the patient’s medical history, symptoms, and additional diagnostic tests. For a final clinical diagnosis, further confirmatory testing, such as echocardiography, is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250649: Bunkerhill ECG-EF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250649
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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