Hypertension Notification Feature (HTNF)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Apple Inc.
Identifiers
- 510(k) Number
- K250507 FDA 510(k)
- FDA Product Code
- SFR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2380 FDA 510(k)
- Regulation Number
- 870.2380 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hypertension Notification Feature (HTNF) is a machine learning-based software designed to monitor and assess blood pressure data. It functions as an automated alert system, identifying elevated hypertension readings and notifying users via their Apple device to encourage timely medical attention or intervention.
HTNF is supplied as a digital feature integrated into compatible Apple devices and is intended for single-use per monitoring session. It operates under FDA 510(k) clearance (K250507) and EU MDR compliance, with no physical sterility requirements. The software does not interact with MRI environments and is available globally through Apple’s app ecosystem, requiring no additional storage beyond the device’s memory.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250507 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Apple Inc.
- FDA Applicant
- Apple, Inc.
Sources (2)
- FDA 510(k) K250507 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026