# Proteus Digital Health, Inc.

- Location (FDA's records): Redwood City, CA
- FDA decisions: 4 (2013–2015): 4 510(k) clearances
- Product codes: OZW (4)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 6 (3 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 Biomedical, Inc.: 2 (https://510kreport.com/company/proteus-biomedical)

## Firms that cite its devices most
- Otsuka America Pharmaceutical, Inc.: 2 (https://510kreport.com/company/otsuka-america-pharmaceutical)
- Etectrx, Inc.: 1 (https://510kreport.com/company/etectrx)

## Its most-cited devices
- K133263: Proteus Patch, Proteus Ingestible Sensor (Accessory) (2014), cited by 2
- K150494: Proteus Digital Health Feedback Device (2015), cited by 2
- K131009: Proteus Patch, Ingestible Sensor (Accessory) (2013), cited by 2

## Recent decisions
- K150494: Proteus Digital Health Feedback Device (Jun 27, 2015)
- K133263: Proteus Patch, Proteus Ingestible Sensor (Accessory) (Feb 7, 2014)
- K131524: Proteus Patch Including Ingestible Sensor (Jun 23, 2013)
- K131009: Proteus Patch, Ingestible Sensor (Accessory) (May 7, 2013)

Source page: https://510kreport.com/company/proteus-digital-health