510(k) · Cleared
ClearedTempus ECG-AF
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 Jun 21, 2024 as substantially equivalent to DEN230003 (Viz. Ai, Inc., 2023) after a 231-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Jun 21, 2024
- Review
- 231 days
- Class
- Class II
- Product code
- SBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230003 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230003 Viz HCMViz. Ai, Inc. · 2023
- This deviceK233549 Tempus ECG-AFTempus AI, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023 | — |
| 0 (this device) | K233549 | Tempus ECG-AF | Tempus AI, Inc. | 2024 | — |
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 K254297 Tempus ECG-MRscore 13.0 · 4 generations · 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 |
|---|---|---|---|
| * | DEN230003 | Viz HCMSummary page 5…21 CFR § 870.2380 Product Code: SBQ Predicate Device: Viz HCM Submission Number: DEN230003 Product Code: QXO Indications For Use Tempus ECG-AF is intended for use to analyze record… | 2023 |
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate DEN230003.
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. 2024, 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-AF is intended for use to analyze recordings of 12-lead ECG devices and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. It is for use on resting 12-lead ECG recordings collected at a healthcare facility from patients: • 65 years of age or older, • without pre-existing or concurrent documentation of atrial fibrillation and/or atrial…
Read the full statement (240 words)
Tempus ECG-AF is intended for use to analyze recordings of 12-lead ECG devices and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. It is for use on resting 12-lead ECG recordings collected at a healthcare facility from patients:
• 65 years of age or older,
• without pre-existing or concurrent documentation of atrial fibrillation and/or atrial flutter,
• who do not have a pacemaker or implantable cardioverter defibrillator, and
• who did not have cardiac surgery within the preceding 30 days.
Performance of repeated testing of the same patient over time has not been evaluated and results SHOULD NOT be used for patient monitoring.
Tempus ECG-AF only analyzes ECG data. 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. Tempus ECG-AF is not for use in patients with a history of AF, unless the AF occurred after a cardiac surgery procedure and resolved within 30 days of the procedure. It is not for use to assess risk of occurrence of AF related to cardiac surgery.
Results do not describe a person’s overall risk of experiencing AF or serve as the sole basis for diagnosis of AF, and should not be used as the basis for treatment of AF.
Results are not intended to rule out AF follow-up.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233549 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233549: Tempus ECG-AF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233549
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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