# FJK: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 77
- 510(k) review time 2021–2025: median 251 days (middle half 171–325)
- Recalls: 10 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2012: 2
- 2014: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2021: 3
- 2023: 1
- 2024: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- K072024: Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693 (2007), cited by 6
- K080807: Blood Tubing Sets (Sterile Fluid Path) (2008), cited by 3
- K953823: Arterial Venous Blood Tubing Set (1996), cited by 3
- K971313: NMC Hemodialysis Arterial Blood Tubing Set (1997), cited by 2
- K161582: DORA Tubing Sets for Hemodialysis (2017), cited by 2
- K140841: Tablo Cartridge (2014), cited by 2
- K201866: NovaLine Tubing Sets for Hemodialysis (2021), cited by 2
- K001107: Fresenius Combilines Low Volume Blood Tubing Set,  Models 03-2291 (Post Pump) and 03-2292 (Pre-Pump) (2000), cited by 2
- K962081: Combilines Hemodialysis Blood Tubing Set (1996), cited by 2
- K000451: Fresenius Combillines Single Needle Blood Tubing Set, Catalog #03-2290 (2000), cited by 2

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