510(k) · Cleared
ClearedTempus ECG-PH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tempus AI, Inc. · SAT Pulmonary Hypertension Machine Learning-Based Notification Software
Cleared on Aug 21, 2026 as substantially equivalent to K233666 (Analytics For Life, Inc., 2024) after a 270-day review. Its family tree reaches back 3 generations to 2023.
- Decided
- Aug 21, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- SAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 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 SAT? 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 SAT device
- #1 K252360 ECG-AI Pulmonary Hypertension (PH) 12-Lead…score 14.7 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K233666 | CorVista System with PH Add-OnSummary page 5…Product Code: SAT Predicate Device: CorVista System with PH Add-On Submission Number: K233666 Product Code: SAT Indications For Use Tempus ECG-PH is software intended to analyze restin… | 2024 |
| † | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | 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 4 companies; a new generation was cleared every 7 months on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K233666.
How does its category compare?
All SAT devicesSAT Pulmonary Hypertension 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 · SAT
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SAT
Too few SAT 510(k)s in any year since 2007 to give a median.
Recalls per year · SAT
No recall names SAT since 2007.
Adverse event reports per year · SAT
No MAUDE report names SAT 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 | 2 | — | 0 | — |
What is it indicated for?
Tempus ECG-PH is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with a patient having elevated mean pulmonary artery pressure (mPAP > 20 mmHg), an indicator of pulmonary hypertension (PH). It is for use on clinical diagnostic 12-lead ECG recordings collected at a healthcare facility from patients: • 40 years of age or older • with cardiovascular symptoms (dyspnea, fatigue, chest pain, or edema) •…
Read the full statement (151 words)
Tempus ECG-PH is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with a patient having elevated mean pulmonary artery pressure (mPAP > 20 mmHg), an indicator of pulmonary hypertension (PH). It is for use on clinical diagnostic 12-lead ECG recordings collected at a healthcare facility from patients:
• 40 years of age or older
• with cardiovascular symptoms (dyspnea, fatigue, chest pain, or edema)
• who do not have a known history of PH
Tempus ECG-PH only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-PH is not intended to be a stand-alone diagnostic tool for PH, should not be used for serial patient monitoring, and should not be used on ECGs with paced rhythms. Results should always be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings, as well as the patient’s symptoms, other tests, and clinical history.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253699 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253699: Tempus ECG-PH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253699
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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