K250649 is an FDA 510(k) clearance for the Bunkerhill ECG-EF. This device is classified as a Reduced Ejection Fraction Machine Learning-based Notification Software (Class II - Special Controls, product code QYE).
Submitted by BunkerHill Health (San Francisco, US). The FDA issued a Cleared decision on September 19, 2025, 199 days after receiving the submission on March 4, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2380. Reduced Ejection Fraction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Reduced Ejection Fraction For Further Referral Or Diagnostic Follow-up..
| 510(k) Number | K250649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2025 |
| Decision Date | September 19, 2025 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QYE — Reduced Ejection Fraction Machine Learning-based Notification Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2380 |
| Definition | Reduced Ejection Fraction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Reduced Ejection Fraction For Further Referral Or Diagnostic Follow-up. |