# Otsuka America Pharmaceutical, Inc.

- Location (FDA's records): Rockville, MD
- FDA decisions: 3 (2023–2025): 3 510(k) clearances
- Product codes: OZW (2), SAP (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 2 (1 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
- Proteus Digital Health, Inc.: 2 (https://510kreport.com/company/proteus-digital-health)
- Pear Therapeutics, Inc.: 1 (https://510kreport.com/company/pear-therapeutics)

## Firms that cite its devices most
- Click Therapeutics, Inc.: 1 (https://510kreport.com/company/click-therapeutics)

## Its most-cited devices
- K223463: Otsuka Digital Feedback Device-RW (2023), cited by 1
- K231209: Rejoyn (2024), cited by 1

## Recent decisions
- K251088: Otsuka Digital Feedback Device (Jun 30, 2025)
- K231209: Rejoyn (Mar 30, 2024)
- K223463: Otsuka Digital Feedback Device-RW (Aug 11, 2023)

Source page: https://510kreport.com/company/otsuka-america-pharmaceutical