FDA product code SAT: Pulmonary Hypertension Machine Learning-Based Notification Software
SAT is the FDA product code for pulmonary hypertension machine learning-based notification software. It is a Class II device, regulated under 21 CFR 870.2380 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under SAT, 3 in the last five years, from 3 different applicants. The average 510(k) review took 218 days (median 242); 199 days on average over the last three years.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Pulmonary Hypertension Machine Learning-Based Notification Software |
| Device class | Class II |
| Regulation | 21 CFR 870.2380 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for SAT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 142 |
| 2026 | 2 | 256 |
Compare with all 510(k) review times · Search every SAT clearance
Top SAT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tempus AI, Inc. | 1 | 2026-08-21 |
| Anumana, Inc. | 1 | 2026-03-28 |
| Analytics For Life, Inc. | 1 | 2024-04-05 |
Most recent SAT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253699 | Tempus AI, Inc. | Tempus ECG-PH | 2026-08-21 | 270 |
| K252360 | Anumana, Inc. | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | 2026-03-28 | 242 |
| K233666 | Analytics For Life, Inc. | CorVista System with PH Add-On | 2024-04-05 | 142 |
Recalls for SAT devices
openFDA lists no recalls for product code SAT.
Frequently asked questions
What is FDA product code SAT?
SAT is the FDA product code for pulmonary hypertension machine learning-based notification software. It is a Class II device, regulated under 21 CFR 870.2380 and reviewed by the Cardiovascular panel.
What device class is SAT?
Class II, regulation 21 CFR 870.2380. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAT?
Across 3 cleared submissions the average was 218 days from receipt to decision (median 242).
Which companies have the most SAT clearances?
Tempus AI, Inc. (1); Anumana, Inc. (1); Analytics For Life, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SAT
- Run a recall and safety report across every SAT manufacturer
- Watch product code SAT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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