# SAT: Pulmonary Hypertension Machine Learning-Based Notification Software

- Device class: 2; regulation: 21 CFR 870.2380; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 142 days (middle half 142–142)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2024: 1
- 2026: 2

## Most-cited predicates
- K233666: CorVista System with PH Add-On (2024), cited by 2
- K252360: ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (2026), cited by 1

Source page: https://510kreport.com/product-code/SAT
Data by year (CSV): https://510kreport.com/product-code/SAT.csv