FDA applicant

Otsuka America Pharmaceutical, Inc.

Rockville, MD3 decisions2023–20250 recalls

FDA records 3 decisions for Otsuka America Pharmaceutical, Inc. (Rockville, MD) from 2023 to 2025: 3 510(k) clearances. Most are in product codes OZW (Ingestible Event Marker) and SAP (Computerized Behavioral Therapy Device For…). Its devices cite 4 predicates, 1 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2025

2023high 1 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Otsuka America Pharmaceutical, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Otsuka America Pharmaceutical, 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 “Otsuka”

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

Otsuka Pharmaceutical Co., Ltd. 6 Otsuka Electronics USA, Inc. 2 Otsuka Electronics 2

Otsuka America Pharmaceutical, 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 “Otsuka”