Tempus ECG-PH— 510(k) K253699

Substantially Equivalent

Tempus AI, Inc.

FDA 510(k) clearance K253699 for Tempus ECG-PH, Substantially Equivalent on 2026-08-21. Applicant: Tempus AI, Inc.. Device class: 2.

Clearance details

Applicant: Tempus AI, Inc.
Product code: Code SAT
Device class: Class 2
Regulation: 21 CFR 870.2380
Advisory panel: Cardiovascular
Date received: 2025-11-24
Decision date: 2026-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code SAT

K252360 — ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)2026-03-28
K233666 — CorVista System with PH Add-On2024-04-05

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