Chrysalis Intelligence · Sponsors · Otsuka America Pharmaceutical, Inc.

Otsuka America Pharmaceutical, Inc.

Hayward, CA, US · 3 510(k) clearances

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Total clearances
3
2023-08-11 → 2025-06-30
Last 12 months
0
Product codes
2
Most recent
2025-06-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OZW Ingestible Event Marker Class II General Hospital 2 2025-06-30
SAP Computerized Behavioral Therapy Device For Depressive Disorders. Class II Neurology 1 2024-03-30
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2025-06-30 K251088 Otsuka Digital Feedback Device OZW Class II General Hospital
2024-03-30 K231209 Rejoyn SAP Class II Neurology
2023-08-11 K223463 Otsuka Digital Feedback Device-RW OZW Class II General Hospital
Data source: openFDA · Generated 2026-08-11 12:14 · Last ingest 2026-08-11T16:13:49.849860 · Pipeline: Chrysalis Intelligence