# KGZ: Accessories, Catheter

- Device class: 1; regulation: 21 CFR 878.4200; FDA's rule: 510(k) exempt
- FDA decisions: 29
- Recalls: 12 (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)
- 1981: 2
- 1982: 2
- 1984: 1
- 1986: 2
- 1987: 2
- 1989: 3
- 1994: 1
- 1996: 1
- 1998: 2
- 2002: 1

## Most-cited predicates
- K760385: Extension Sets (1976), cited by 1
- K955433: Duralastic Silicone Tubing (1996), cited by 1

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