# FPK: Tubing, Fluid Delivery

- Device class: 2; regulation: 21 CFR 880.5440; FDA's rule: 510(k) required
- FDA decisions: 64
- Recalls: 27 (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)
- 1994: 2
- 1995: 10
- 1997: 1
- 2002: 1
- 2003: 1
- 2004: 1
- 2005: 1
- 2006: 1
- 2007: 1
- 2013: 1

## Most-cited predicates
- K022431: Medrad Transfer Set (2002), cited by 4
- K041178: Empower Transfer Set, (Cat. NO. 7725) (2004), cited by 2
- K800825: Extension Set Quest Code #3000 (1980), cited by 2
- K031808: Medrad Swabbable Valve Transfer Set (2003), cited by 2
- K063239: Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 & 17526 (2006), cited by 2
- K884370: CMS IV Extension Sets (1988), cited by 1
- K941214: Lifeshield Extension Set (1994), cited by 1
- K883718: Merit HI-Flex (TM) (1989), cited by 1
- K912103: Lifeshield Extension Set (1991), cited by 1
- K950508: Sysmex SF-3000 (1995), cited by 1

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