510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233549Substantially Equivalent

Tempus ECG-AF

TEMPUS AI, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233549 is the FDA 510(k) clearance record for Tempus ECG-AF, a class II device, cleared for Tempus AI, Inc. on under FDA product code SBQ (Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software). FDA's definition for product code SBQ reads: "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". FDA records list 3 510(k) clearances for Tempus AI, Inc., from to . As of , FDA records show no recalls naming K233549.

Clearance record

Decision date
Received
(231 days to decision)
Product code
SBQ Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Applicant
Tempus AI, Inc. 600 W Chicago Ave., Chicago IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SBQ

Trailing 12 months
1 clearance under product code SBQ in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SBQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260