Cleared Traditional

K253699 - Tempus ECG-PH

K253699 is an FDA 510(k) clearance for Tempus ECG-PH, manufactured by Tempus AI, Inc.. The device is a Class 2 Cardiovascular device with product code SAT cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K253699 · Tempus AI, Inc. · Cardiovascular device
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Aug 2026
Decision
270d
Days
Class 2
Risk

K253699 is an FDA 510(k) clearance for the Tempus ECG-PH. Classified as Pulmonary Hypertension Machine Learning-based Notification Software (product code SAT), Class II - Special Controls.

Submitted by Tempus AI, Inc. (Chicago, US). The FDA issued a Cleared decision on August 21, 2026 after a review of 270 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2380 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Tempus AI, Inc. devices

FDA 510(k) Submission Details - K253699

510(k) Number K253699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2025
Decision Date August 21, 2026
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

SAT Device Classification - Class 2, Special Controls

Product Code SAT Pulmonary Hypertension Machine Learning-based Notification Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2380
Definition Pulmonary Hypertension Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Pulmonary Hypertension For Further Referral Or Diagnostic Follow-up.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.