Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Tempus. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Tempus AI with 5 510(k) clearances and 2 AI-enabled devices. The most recent is a 510(k) clearance dated Sep 25, 2026: Tempus ECG-MR.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 25, 2026 | Tempus ECG-MRK254297 · SBQ | 510(k) clearances |
| Aug 21, 2026 | Tempus ECG-PHK253699 · SAT | 510(k) clearances |
| Sep 19, 2025 | xR IVDK241868 · PZM | 510(k) clearances |
| Jul 15, 2025 | Tempus ECG-Low EFK250119 · QYE | 510(k) clearances |
| Jul 15, 2025 | Tempus ECG-Low EFK250119 · Cardiovascular | AI-enabled devices |
| Jun 21, 2024 | Tempus ECG-AFK233549 · SBQ | 510(k) clearances |
| Jun 21, 2024 | Tempus ECG-AFK233549 · Cardiovascular | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
