TEMPUS AI, Inc.

FDA Device Registration & Listing · Chicago, IL, US · Registration 3013200421

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013200421
FEI Number
3013200421
Entity Name
TEMPUS AI, Inc.
City/State/Country
Chicago, IL, US
Establishment Address
600 W Chicago Ave #510, Chicago, IL 60654, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Tempus AI, Inc. (Owner Number: 10088107)
Owner / Operator Contact Address
600 W Chicago Ave #510, Chicago, IL 60654, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233549
PMA Number
N/A

All Registered Proprietary Names

xR IVD xT CDx Tempus ECG-Low EF Tempus ECG-AF

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PZM Next Generation Sequencing Based Tumor Profiling Test Pathology Class 2 866.6080 2026-05-01
PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown Class 3 N/A 2023-05-25
QYE Reduced Ejection Fraction Machine Learning-Based Notification Software Cardiovascular Class 2 870.2380 2025-07-22
SBQ Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software Cardiovascular Class 2 870.2380 2024-08-08

Official Correspondent

Elaine Katrivanos

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tempus AI, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013200421. Last updated year: 2026. Please use registration number 3013200421 when referencing this establishment in official correspondence.
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