Cleared Traditional

K254297 - Tempus ECG-MR

K254297 is an FDA 510(k) clearance for Tempus ECG-MR, manufactured by Tempus AI, Inc.. The device is a Class 2 Cardiovascular device with product code SBQ cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K254297 · Tempus AI, Inc. · Cardiovascular device
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Sep 2026
Decision
268d
Days
Class 2
Risk

K254297 is an FDA 510(k) clearance for the Tempus ECG-MR. Classified as Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software (product code SBQ), Class II - Special Controls.

Submitted by Tempus AI, Inc. (Chicago, US). The FDA issued a Cleared decision on September 25, 2026 after a review of 268 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 - K254297

510(k) Number K254297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2025
Decision Date September 25, 2026
Days to Decision 268 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
143d slower than avg
Panel avg: 125d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

SBQ Device Classification - Class 2, Special Controls

Product Code SBQ Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2380
Definition Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Future Occurrence Of Atrial Fibrillation 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.

Regulatory Peers - SBQ Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software

Devices cleared under the same product code (SBQ) and FDA review panel - the closest regulatory comparables to K254297.
Tempus ECG-AF
K233549 · Tempus AI, Inc. · Jun 2024