K252360 is an FDA 510(k) clearance for the ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020). This device is classified as a Pulmonary Hypertension Machine Learning-based Notification Software (Class II - Special Controls, product code SAT).
Submitted by Anumana, Inc. (Cambridge, US). The FDA issued a Cleared decision on March 28, 2026, 242 days after receiving the submission on July 29, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2380. 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..
| 510(k) Number | K252360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2025 |
| Decision Date | March 28, 2026 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | SAT - Pulmonary Hypertension Machine Learning-based Notification Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2380 |
| 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. |