ClearanceBrief
Company ยท US

Tempus AI, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2024 to 2026. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
SBQAtrial Fibrillation Risk Prediction Machine Learning-Based Notification Software2
PZMNext Generation Sequencing Based Tumor Profiling Test1
QYEReduced Ejection Fraction Machine Learning-Based Notification Software1
SATPulmonary Hypertension Machine Learning-Based Notification Software1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 25, 2026K254297Tempus ECG-MR
Tempus AI, Inc.
SBQ
Aug 21, 2026K253699Tempus ECG-PH
Tempus AI, Inc.
SAT
Sep 19, 2025K241868xR IVD
Tempus AI, Inc.
PZM
Jul 15, 2025K250119Tempus ECG-Low EF
Tempus AI, Inc.
QYE
Jun 21, 2024K233549Tempus ECG-AF
Tempus AI, Inc.
SBQ

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
Get alerts for these product codes