Apple, Inc. - FDA 510(k) Cleared Devices

Apple, Inc. is a technology company that develops consumer electronics and digital health solutions. The company operates with a manufacturing facility in Alexandria, US, and has expanded into medical device development through FDA-regulated health features integrated into its consumer products.

Apple has received 9 FDA 510(k) clearances from 12 total submissions since its first clearance in 2018. The company's cleared devices focus primarily on cardiovascular monitoring and ophthalmic applications, with recent clearances including notification features for hypertension, irregular rhythm detection, atrial fibrillation history tracking, and digital prism correction capabilities. The company remains actively engaged in FDA regulatory pathways, with its latest clearance in 2025.

Apple's medical device portfolio reflects integration of health monitoring into wearable and mobile platforms. Features span cardiac rhythm assessment, sleep apnea detection, and vision correction technologies. These devices leverage the company's existing ecosystem of iPhones, Apple Watches, and related applications to deliver clinical functionality at consumer scale.

Explore the complete list of device names, product codes, and individual clearance dates in the database to review Apple's full regulatory history and cleared device specifications.

1 device has linked clinical trial registered on ClinicalTrials.gov. 2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.