FDA applicant

Apple, Inc.

Cupertino, CA12 decisions2018–20260 recalls

FDA records 12 decisions for Apple, Inc. (Cupertino, CA) from 2018 to 2026: 9 510(k) clearances and 3 De Novo grants. Most are in product codes QDB (Photoplethysmograph Analysis Software For…) and SCW (Digital Prismatic Correction). Its devices cite 6 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Apple, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2018high 3 (2024) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Apple, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Apple, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Apple”

FDA records each applicant name separately; these may or may not be the same firm.

Apple Medical Corp. 9 Apple Diagnostic Products 7

Apple, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Apple”