# DEN120011: Proteus Ingestion Confinmation Systems

- Pathway: De Novo (Post-NSE)
- Applicant: Proteus Biomedical, Inc.
- Decided: Jul 10, 2012 after 60 days
- Product code: OZW (Ingestible Event Marker)
- Device class: 2
- Regulation: 21 CFR 880.6305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K131009: Proteus Patch, Ingestible Sensor (Accessory) (2013), 6 descendants of its own
- K133263: Proteus Patch, Proteus Ingestible Sensor (Accessory) (2014), 4 descendants of its own
- K150494: Proteus Digital Health Feedback Device (2015), 3 descendants of its own
- K223463: Otsuka Digital Feedback Device-RW (2023), 1 descendant of its own
- K251088: Otsuka Digital Feedback Device (2025), 0 descendants of its own

Source page: https://510kreport.com/device/DEN120011
Methodology: https://510kreport.com/methodology