Apple Inc.

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

5 AI-enabled medical devices from Apple Inc. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2025-09-11	K250507	Hypertension Notification Feature (HTNF)	Apple Inc.	Cardiovascular
2024-09-13	K240929	Sleep Apnea Notification Feature (SANF)	Apple Inc.	Anesthesiology
2023-07-21	K231173	Irregular Rhythm Notification Feature (IRNF)	Apple Inc.	Cardiovascular
2022-06-03	K213971	Atrial Fibrillation History Feature	Apple Inc.	Cardiovascular
2021-10-22	K212516	IRNF App	Apple Inc.	Cardiovascular

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