# Apple, Inc.

- Location (FDA's records): Cupertino, CA
- FDA decisions: 12 (2018–2026): 9 510(k) clearances and 3 De Novo grants
- Product codes: QDB (4), SCW (2), QDA (2), SCR (1), SFR (1), SHN (1), QZW (1)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 18 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Viz. Ai, Inc.: 1 (https://510kreport.com/company/viz-ai)
- Samsung Electronics Co., Ltd.: 1 (https://510kreport.com/company/samsung-electronics)

## Firms that cite its devices most
- Samsung Electronics Co., Ltd.: 5 (https://510kreport.com/company/samsung-electronics)
- Fitbit, Inc.: 2 (https://510kreport.com/company/fitbit)
- AliveCor, Inc.: 1 (https://510kreport.com/company/alivecor)
- Tuned, Ltd.: 1 (https://510kreport.com/company/tuned)
- Whoop., Inc.: 1 (https://510kreport.com/company/whoop)
- Luxottica Group S.P.A.: 1 (https://510kreport.com/company/luxottica-group)
- Withings: 1 (https://510kreport.com/company/withings)
- Garmin International, Inc.: 1 (https://510kreport.com/company/garmin-international)

## Its most-cited devices
- DEN180044: ECG App (2018), cited by 5
- DEN230081: Hearing Aid Feature (HAF) (2024), cited by 4
- DEN180042: Irregular Rhythm Notification Feature (2018), cited by 3
- K201525: ECG App (2020), cited by 3
- K212516: IRNF App (2021), cited by 2
- K240929: Sleep Apnea Notification Feature (SANF) (2024), cited by 1

## Recent decisions
- K253582: Medical Imaging Calibration Feature (MICF) (Apr 1, 2026)
- K250507: Hypertension Notification Feature (HTNF) (Sep 11, 2025)
- K250143: Digital Prism Correction Feature (DPCF) (Jun 23, 2025)
- K242058: Digital Prism Correction Feature (DPCF) (Oct 21, 2024)
- K240929: Sleep Apnea Notification Feature (SANF) (Sep 13, 2024)
- DEN230081: Hearing Aid Feature (HAF) (Sep 12, 2024)
- K231173: Irregular Rhythm Notification Feature (IRNF) (Jul 21, 2023)
- K213971: Atrial Fibrillation History Feature (Jun 3, 2022)

Source page: https://510kreport.com/company/apple