K250507 is an FDA 510(k) clearance for the Hypertension Notification Feature (HTNF). This device is classified as a Hypertension Machine Learning-based Notification Software (Class II - Special Controls, product code SFR).
Submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on September 11, 2025, 202 days after receiving the submission on February 21, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2380. Hypertension Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Hypertension For Further Referral Or Diagnostic Follow-up..
| 510(k) Number | K250507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2025 |
| Decision Date | September 11, 2025 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | SFR - Hypertension Machine Learning-based Notification Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2380 |
| Definition | Hypertension Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Hypertension For Further Referral Or Diagnostic Follow-up. |