Tempus AI, Inc.

FDA Regulatory Profile

Tempus AI, Inc. appears in FDA public data with 0 recalls, 4 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 21, 2026.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253699Tempus ECG-PHAugust 21, 2026
K241868xR IVDSeptember 19, 2025
K250119Tempus ECG-Low EFJuly 15, 2025
K233549Tempus ECG-AFJune 21, 2024