# KIT: Media And Components, Synthetic Cell And Tissue Culture

- Device class: 1; regulation: 21 CFR 864.2220; FDA's rule: 510(k) exempt
- FDA decisions: 367
- Recalls: 4 (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)
- 1980: 1
- 1981: 18
- 1982: 27
- 1983: 29
- 1984: 21
- 1985: 68
- 1986: 22
- 1987: 52
- 1988: 124
- 1989: 4

## Most-cited predicates
- K850886: Compression Hip Screw System (1985), cited by 3
- K871250: Intra-Articulated Arthro Power System (1987), cited by 3
- K863696: Arthroscopic Surgical Power Device (1986), cited by 1
- K851606: D-PBS, Products NO. D5652 (1985), cited by 1

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