510(k) K253699
K253699 is an FDA 510(k) premarket notification submitted by Tempus AI, Inc. for the device "Tempus ECG-PH". The FDA issued a decision of Substantially Equivalent on August 21, 2026. The device falls under product code SAT (Pulmonary Hypertension Machine Learning-Based Notification Software), a Class II device regulated under 21 CFR 870.2380. Tempus AI, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2026
- Date Received
- November 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pulmonary Hypertension Machine Learning-Based Notification Software
- Device Class
- Class II
- Regulation Number
- 870.2380
- Review Panel
- CV
- Submission Type
Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up.