# BRZ: Set, Blood Transfusion

- Device class: 2; regulation: 21 CFR 880.5440; FDA's rule: 510(k) required
- FDA decisions: 30
- 510(k) review time 2021–2025: median 194 days (middle half 159–228)
- Recalls: 12 (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)
- 1997: 1
- 1999: 1
- 2000: 1
- 2002: 1
- 2005: 3
- 2008: 1
- 2009: 1
- 2013: 1
- 2021: 1
- 2022: 1

## Most-cited predicates
- K000685: Charter Medical Neonatal Syringe Set (2000), cited by 2
- K993120: Modified Blood Recipient Set (1999), cited by 2
- K210335: Blood Administration Set (2021), cited by 1
- K023039: Blood/Solution Administration Set, Model 33.015 (2002), cited by 1
- K073339: Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector (2008), cited by 1
- K041496: Pentatrasfu  Blood Transfusion Sets (2005), cited by 1
- K050115: Blood Hand Pump Administration Set (2005), cited by 1

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