# NFK: Kit, Repair, Catheter, Hemodialysis

- Device class: 2; regulation: 21 CFR 876.5540; FDA's rule: 510(k) required
- FDA decisions: 11
- 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)
- 2001: 2
- 2002: 4
- 2003: 1
- 2006: 2
- 2009: 1
- 2010: 1

## Most-cited predicates
- K011015: Catheter Repair Kit with Replacement Connector, Model 5587000 (2001), cited by 3
- K063446: Catheter Repair Kit with Replacement Connector, Model 5587000 (2006), cited by 2
- K030442: Catheter Repair Kit with Replacement Connector, Model 5587000 (2003), cited by 1
- K022561: Catheter Repair Kit with Replacement Connector, Model 5587000 (2002), cited by 1
- K020430: Diatek Connector Assembly Replacement Kit (Cark) (2002), cited by 1
- K022644: Retro Repair Kit, Model PRRK5 (2002), cited by 1

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