Cleared Traditional

K233549 - Tempus ECG-AF

K233549 is an FDA 510(k) clearance for Tempus ECG-AF, 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 231-day FDA review.

K233549 · Tempus AI, Inc. · Cardiovascular device
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Jun 2024
Decision
231d
Days
Class 2
Risk

K233549 is an FDA 510(k) clearance for the Tempus ECG-AF. 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 June 21, 2024 after a review of 231 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 - K233549

510(k) Number K233549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2023
Decision Date June 21, 2024
Days to Decision 231 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 125d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.