# KDC: Instrument, Surgical, Disposable

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 67
- Recalls: 33 (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: 16
- 1982: 5
- 1983: 12
- 1984: 3
- 1985: 1
- 1986: 7
- 1990: 3
- 1991: 3
- 1992: 4
- 1994: 2

## Most-cited predicates
- K811280: Flex-Template (1981), cited by 1
- K822065: Kam Sucker (1982), cited by 1
- K780880: Y-Type Blood Set (1978), cited by 1

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