Tempus ECG-PH— 510(k) K253699
Substantially EquivalentTempus AI, Inc.
FDA 510(k) clearance K253699 for Tempus ECG-PH, Substantially Equivalent on 2026-08-21. Applicant: Tempus AI, Inc.. Device class: 2.
Summary
Tempus AI's Tempus ECG-PH is filed under product code SAT, pulmonary hypertension machine learning-based notification software. The record has no description beyond the name and that code name.
Class II, 21 CFR 870.2380. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Tempus filed from Chicago, Illinois. The substantially equivalent decision came 270 calendar days after receipt (November 24, 2025 to August 21, 2026).
Clearance details
- Applicant
- Tempus AI, Inc.
- Product code
- Product code SAT
- 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 SAT
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