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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K250507

510(k) cleared

Hypertension Notification Feature (HTNF)

Apple, Inc. · Sep 11, 2025 · K250507

FDA cleared the Hypertension Notification Feature (HTNF) from Apple, Inc. on Sep 11, 2025 under K250507, a traditional 510(k). The device falls under product code SFR, Hypertension Machine Learning-Based Notification Software, regulated at 21 CFR 870.2380 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 21, 2025. The decision came 202 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Apple, Inc. has one other decision in the tracker over the last 12 months: K253582 (Medical Imaging Calibration Feature (MICF)).

Questions & Answers

What did FDA clear under K250507?

K250507 is the FDA 510(k) for Hypertension Notification Feature (HTNF), submitted by Apple, Inc.. FDA's decision date was Sep 11, 2025, under product code SFR (Hypertension Machine Learning-Based Notification Software).

Who makes the Hypertension Notification Feature (HTNF)?

Apple, Inc., based in Cupertino, CA, is the applicant of record for K250507.

How long did the K250507 review take?

FDA received the submission on Feb 21, 2025 and issued its decision on Sep 11, 2025, 202 days later.

← All decisions in September 2025

Sources