# ODX: Autonomous Extracorporeal Blood Leak Detector/Alarm

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 4
- Recalls: 1 (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)
- 2007: 1
- 2010: 1
- 2011: 1
- 2013: 1

## Most-cited predicates
- K071013: Redsense (2007), cited by 3
- K092955: Redsense-Home Use (2010), cited by 2
- K103242: Redsense-Alarm Unit and Sensor (2011), cited by 1

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