# FIB: Protector, Transducer, Dialysis

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 35
- 510(k) review time 2021–2025: median 158 days (middle half 158–158)
- 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)
- 1990: 4
- 1991: 4
- 1992: 1
- 1994: 2
- 1997: 2
- 1998: 1
- 2000: 3
- 2001: 2
- 2008: 1
- 2024: 1

## Most-cited predicates
- K895856: Medisystems Transducer Protector (1989), cited by 2
- K010264: Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set (2001), cited by 2
- K934069: Millex, Dualex (Plus, Ultra) (1994), cited by 1
- K001465: Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set (2000), cited by 1
- K964337: Better-Bladder (BB) (1997), cited by 1
- K001971: Hemodialysis Tubing Sets (2001), cited by 1
- K983076: Medisystems Transducer Protector (1998), cited by 1
- K072988: Nipro Transducer Protector TP-Sure, Model Tpsure+1 (2008), cited by 1

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