# OZW: Ingestible Event Marker

- Device class: 2; regulation: 21 CFR 880.6305; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 175 days (middle half 129–222)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2012: 1
- 2013: 2
- 2014: 1
- 2015: 1
- 2019: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- 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
- K223463: Otsuka Digital Feedback Device-RW (2023), cited by 1
- DEN120011: Proteus Ingestion Confinmation Systems (2012), cited by 1

Source page: https://510kreport.com/product-code/OZW
Data by year (CSV): https://510kreport.com/product-code/OZW.csv