K250119 is an FDA 510(k) clearance for the Tempus ECG-Low EF. This device is classified as a Reduced Ejection Fraction Machine Learning-based Notification Software (Class II - Special Controls, product code QYE).
Submitted by Tempus AI, Inc. (Chicago, US). The FDA issued a Cleared decision on July 15, 2025, 180 days after receiving the submission on January 16, 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 | K250119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2025 |
| Decision Date | July 15, 2025 |
| Days to Decision | 180 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. |