510(k) · Cleared
ClearedTempus ECG-MR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tempus AI, Inc. · SBQ Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
Cleared on Sep 25, 2026 as substantially equivalent to K252360 (Anumana, Inc., 2026) after a 268-day review. Its family tree reaches back 4 generations to 2023.
- Decided
- Sep 25, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- SBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN230003 (2023). No later device cites it as a predicate yet.
- Root · 4 generations backDEN230003 Viz HCMViz. Ai, Inc. · 2023
- 3 generations backK232699 Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. · 2023
- 2 generations backK250652 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc. · 2025
- 1 generation backK252360 ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc. · 2026
- This deviceK254297 Tempus ECG-MRTempus AI, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023 | — |
| −3 | K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | 2023 | — |
| −2 | 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 | — |
| 0 (this device) | K254297 | Tempus ECG-MR | Tempus AI, Inc. | 2026 | — |
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 SBQ? 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 SBQ device
- #1 K233549 Tempus ECG-AFscore 7.6 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) Cleared while this submission was under review Summary page 5…SIJ Predicate Device: Anumana ECG-AI Pulmonary Hypertension 12-Lead algorithm Submission Number: K252360 Product Code: SAT Indications For Use Tempus ECG-MR is software intended to analyze resting, non-amb… | 2026 |
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 3 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All SBQ devicesSBQ Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SBQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SBQ
Too few SBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · SBQ
No recall names SBQ since 2007.
Adverse event reports per year · SBQ
No MAUDE report names SBQ 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 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Tempus ECG-MR is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having moderate or severe mitral regurgitation (MR). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients: • 65 years of age or older • At risk of cardiovascular disease. Such cardiovascular risk factors include, but are not limited to, history of coronary artery disease…
Read the full statement (178 words)
Tempus ECG-MR is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having moderate or severe mitral regurgitation (MR). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients:
• 65 years of age or older
• At risk of cardiovascular disease. Such cardiovascular risk factors include, but are not limited to, history of coronary artery disease, hypertension, obesity, or diabetes; or other signs or symptoms of heart disease, such as dyspnea, chest pain, or lower extremity edema.
• Without prior mitral valve intervention
• Without prior diagnosis of moderate or severe mitral regurgitation
Tempus ECG-MR only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-MR is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for serial 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254297: Tempus ECG-MR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254297
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026