Tempus ECG-MR— 510(k) K254297
Substantially EquivalentTempus AI, Inc.
FDA 510(k) clearance K254297 for Tempus ECG-MR, Substantially Equivalent on 2026-09-25. Applicant: Tempus AI, Inc.. Device class: 2.
Summary
Tempus ECG-MR is filed under SBQ, atrial fibrillation risk prediction machine learning-based notification software. Software in this code uses machine learning to flag patients at higher risk of atrial fibrillation. The device name indicates ECG input; the record doesn't describe the model further.
Class II, 21 CFR 870.2380. The Cardiovascular panel reviewed it as a Traditional 510(k).
Tempus AI, Inc. filed from Chicago, Illinois. Review took 268 days (December 31, 2025 to September 25, 2026).
Clearance details
- Applicant
- Tempus AI, Inc.
- Product code
- Product code SBQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code SBQ
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