# PBZ: Image Processing Device For Estimation Of External Blood Loss

- Device class: 2; regulation: 21 CFR 880.2750; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 167 days (middle half 167–167)
- 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)
- 2014: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- DEN130015: Pixel 3 System (2014), cited by 2
- K160338: Triton System (2016), cited by 1
- K232250: SurgiCount+ System (2024), cited by 1
- K163507: Triton Sponge System (2017), cited by 1

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