Company profile

Apple Inc.

Apple Inc. has 5 AI-enabled medical devices on the FDA list. The first decision was on October 22, 2021 and the most recent on September 11, 2025 (Hypertension Notification Feature (HTNF)). Its most common review panel is Cardiovascular (4 devices).

5AI devices

2021First decision

2025Latest decision

2Specialties

Per year

20212022202320242025

Apple Inc. AI devices per year: 2021 1, 2022 1, 2023 1, 2024 1, 2025 1

By specialty

Cardiovascular4
Anesthesiology1

Related guides

Top cardiovascular devices

Timeline

September 11, 2025 · 510(k) K250507Hypertension Notification Feature (HTNF) · Cardiovascular · SFR
September 13, 2024 · 510(k) K240929Sleep Apnea Notification Feature (SANF) · Anesthesiology · QZW
July 21, 2023 · 510(k) K231173Irregular Rhythm Notification Feature (IRNF) · Cardiovascular · QDB
June 3, 2022 · 510(k) K213971Atrial Fibrillation History Feature · Cardiovascular · QDB
October 22, 2021 · 510(k) K212516IRNF App · Cardiovascular · QDB