Data / Medical devices / United States / TEMPUS AI, Inc.
TEMPUS AI, Inc.: FDA-registered device maker in Chicago, IL, United States, 4 510(k) clearances and 1 PMA approval
TEMPUS AI, Inc. is registered with the FDA (registration 3013200421) in Chicago, IL, United States. It lists 5 device types. The FDA files 4 510(k) clearances and 1 PMA approval under its listings, the newest dated August 21, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013200421
- Address
- 600 W Chicago Ave #510, Chicago, IL, United States, 60654
- Owner or operator
- Tempus AI, Inc. (10088107)
- Roles
- Manufacturer
- First device listed
- May 25, 2023
- Registered through
- 2027
- Brand names listed
- Tempus ECG-AF, Tempus ECG-Low EF, Tempus ECG-PH, xR IVD, xT CDx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software | SBQ | 2 | Manufacturer | accessdata.fda.gov |
| Next Generation Sequencing Based Tumor Profiling Test | PZM | 2 | Manufacturer | accessdata.fda.gov |
| Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | PQP | 3 | Manufacturer | accessdata.fda.gov |
| Pulmonary Hypertension Machine Learning-Based Notification Software | SAT | 2 | Manufacturer | accessdata.fda.gov |
| Reduced Ejection Fraction Machine Learning-Based Notification Software | QYE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2026 | K253699 | Tempus ECG-PH | SAT | Substantially Equivalent | Tempus AI, Inc. | accessdata.fda.gov |
| September 19, 2025 | K241868 | xR IVD | PZM | Substantially Equivalent | Tempus AI, Inc. | accessdata.fda.gov |
| July 15, 2025 | K250119 | Tempus ECG-Low EF | QYE | Substantially Equivalent | Tempus AI, Inc. | accessdata.fda.gov |
| June 21, 2024 | K233549 | Tempus ECG-AF | SBQ | Substantially Equivalent | Tempus AI, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 28, 2023 | P210011 | xT CDx | PQP | 5 | October 23, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- All makers of Next Generation Sequencing Based Tumor Profiling Test
- All makers of Pulmonary Hypertension Machine Learning-Based Notification Software
- All makers of Reduced Ejection Fraction Machine Learning-Based Notification Software
Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.