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Apple, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250507Hypertension Notification Feature (HTNF)September 11, 2025
K250143Digital Prism Correction Feature (DPCF)June 23, 2025
K242058Digital Prism Correction Feature (DPCF)October 21, 2024
K240929Sleep Apnea Notification Feature (SANF)September 13, 2024
DEN230081Hearing Aid Feature (HAF)September 12, 2024
K231173Irregular Rhythm Notification Feature (IRNF)July 21, 2023
K213971Atrial Fibrillation History FeatureJune 3, 2022
K212516IRNF AppOctober 22, 2021
K201525ECG AppOctober 8, 2020
DEN180042Irregular Rhythm Notification FeatureSeptember 11, 2018
DEN180044ECG AppSeptember 11, 2018