# KZD: Infusor, Pressure, For I.V. Bags

- Device class: 1; regulation: 21 CFR 880.5420; FDA's rule: 510(k) exempt
- FDA decisions: 35
- Recalls: 13 (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)
- 1988: 1
- 1989: 1
- 1990: 2
- 1991: 2
- 1992: 1
- 1993: 2
- 1994: 1
- 1995: 2
- 1997: 1
- 1998: 1

## Most-cited predicates
- K822286: Autocuff (Photos Enclosed with 510K (1982), cited by 3
- K800560: MX820-5 Pressure Infusor 500CC MX820-10 (1980), cited by 3
- K820159: Pressure Infuser (1982), cited by 1

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