# KNX: Collector, Urine, (And Accessories) For Indwelling Catheter

- Device class: 2; regulation: 21 CFR 876.5250; FDA's rule: 510(k) exempt
- FDA decisions: 206
- Recalls: 9 (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)
- 1990: 5
- 1991: 3
- 1992: 1
- 1993: 3
- 1994: 5
- 1995: 1
- 1996: 2
- 1997: 6
- 1998: 1
- 2011: 1

## Most-cited predicates
- K862934: Hollister Female Urinary Collection Pouch (1986), cited by 1
- K780837: Urinary Drainage Bag (1978), cited by 1
- K940206: Bard Urine Collection Products Modification (1994), cited by 1
- K843480: Pharma-Plast Urinary Drainage Bag 2000 (1984), cited by 1
- K844810: New Bard Infection Control Urinary Drainage Bag (1985), cited by 1

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