# KZI: Culture Media, Enriched

- Device class: 1; regulation: 21 CFR 866.2330; FDA's rule: 510(k) exempt
- FDA decisions: 51
- Recalls: 2 (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)
- 1982: 1
- 1983: 4
- 1984: 6
- 1985: 9
- 1986: 4
- 1987: 18
- 1988: 9

## Most-cited predicates

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