Tempus AI, Inc.: FDA clearances and approvals
Tempus AI, Inc. has 4 FDA 510(k) clearances (first 2024, latest 2026), plus 1 PMA decision, across 5 product codes in 2 review panels. Median 510(k) review time: 250 days. Since 2017 its median was 250 days, against 235 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov. It files with the SEC as Tempus AI, Inc. (TEM).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 231 |
| 2025 | 2 | 314 |
| 2026 | 1 | 270 |
Review time against the same product codes
Since 2017, Tempus AI, Inc.'s cleared 510(k)s took a median 250 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 235 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | 1 | 0 |
| PZM | Next Generation Sequencing Based Tumor Profiling Test | 1 | 1 |
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software | 1 | 1 |
| SAT | Pulmonary Hypertension Machine Learning-Based Notification Software | 1 | 1 |
| SBQ | Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software | 1 | 1 |
Review panels
- Cardiovascular (3)
- Pathology (2)
Most recent Tempus AI, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253699 | Tempus ECG-PH | SAT | 2026-08-21 | 270 |
| K241868 | xR IVD | PZM | 2025-09-19 | 449 |
| K250119 | Tempus ECG-Low EF | QYE | 2025-07-15 | 180 |
| K233549 | Tempus ECG-AF | SBQ | 2024-06-21 | 231 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P210011 | PMA | xT CDx | 2023-04-28 |
Recalls
openFDA lists no recalls under a recalling firm named Tempus AI, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Tempus AI, Inc. is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06911632: Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary Hypertension (Recruiting, started 2025-07-23)
- NCT06099665: Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform (Completed, started 2024-08-27)
- NCT05442203: Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease (Active not recruiting, started 2022-09-07)
SEC filings
Tempus AI, Inc. (TEM): EDGAR filings, CIK 1717115. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Tempus AI, Inc. have?
Tempus AI, Inc. has 4 FDA 510(k) clearances (first 2024, latest 2026), plus 1 PMA decision, across 5 product codes in 2 review panels.
How long does FDA take to clear Tempus AI, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tempus AI, Inc.'s cleared 510(k)s is 250 days. Since 2017: 250 days, versus 235 days for all cleared 510(k)s in the same product codes.
What devices does Tempus AI, Inc. make?
Its most frequent FDA product codes are PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System, 1); PZM (Next Generation Sequencing Based Tumor Profiling Test, 1); QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software, 1).
Has Tempus AI, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tempus AI, Inc. Related entities may recall under other names.
Next steps
- See all 4 Tempus AI, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PQP, Tempus AI, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.