# KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

- Device class: 2; regulation: 21 CFR 876.5860; FDA's rule: 510(k) required
- FDA decisions: 346
- 510(k) review time 2021–2025: median 216 days (middle half 118–252)
- Recalls: 105 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 8
- 2018: 2
- 2019: 4
- 2020: 9
- 2021: 2
- 2022: 7
- 2023: 7
- 2024: 7
- 2025: 9
- 2026: 6

## Most-cited predicates
- K001250: Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models) (2000), cited by 8
- K946279: Prisma CFM (Continuous Fluid Management System) (1997), cited by 8
- K994267: Fresenius 2008K (2000), cited by 8
- K981681: Prisma CFM (Continuous Fluid Management System) (1998), cited by 7
- K030592: Gambro Polyflux, Model 140H, 170H, 210H (2003), cited by 6
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 (2006), cited by 6
- K013733: System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set (2002), cited by 6
- K982414: Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters (1999), cited by 5
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub (2002), cited by 5
- K041726: High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models Aps-R, -M, -S, -E, and -EX (2004), cited by 5

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