Chrysalis Intelligence · Sponsors · Apple, Inc.

Apple, Inc.

Cupertino, CA, US · 10 510(k) clearances

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Total clearances
10
2020-10-08 → 2026-04-01
Last 12 months
2
Product codes
7
Most recent
2026-04-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QDB Photoplethysmograph Analysis Software For Over-The-Counter Use Class II Cardiovascular 3 2023-07-21
SCW Digital Prismatic Correction Class I Ophthalmic 2 2025-06-23
SHN — — — 1 2026-04-01
SFR Hypertension Machine Learning-Based Notification Software Class II Cardiovascular 1 2025-09-11
QZW — — — 1 2024-09-13
SCR Air-Conduction Hearing Aid Software Class II Ear, Nose, Throat 1 2024-09-12
QDA Electrocardiograph Software For Over-The-Counter Use Class II Cardiovascular 1 2020-10-08
Filings

All 510(k) clearances (10)

Date K-number Device Code Class Specialty
2026-04-01 K253582 Medical Imaging Calibration Feature (MICF) SHN — —
2025-09-11 K250507 Hypertension Notification Feature (HTNF) SFR Class II Cardiovascular
2025-06-23 K250143 Digital Prism Correction Feature (DPCF) SCW Class I Ophthalmic
2024-10-21 K242058 Digital Prism Correction Feature (DPCF) SCW Class I Ophthalmic
2024-09-13 K240929 Sleep Apnea Notification Feature (SANF) QZW — —
2024-09-12 DEN230081 Hearing Aid Feature (HAF) SCR Class II Ear, Nose, Throat
2023-07-21 K231173 Irregular Rhythm Notification Feature (IRNF) QDB Class II Cardiovascular
2022-06-03 K213971 Atrial Fibrillation History Feature QDB Class II Cardiovascular
2021-10-22 K212516 IRNF App QDB Class II Cardiovascular
2020-10-08 K201525 ECG App QDA Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence