# KPA: Slide Stainer, Automated

- Device class: 1; regulation: 21 CFR 864.3800; FDA's rule: 510(k) exempt
- FDA decisions: 21
- Recalls: 17 (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)
- 1977: 3
- 1978: 3
- 1981: 1
- 1982: 1
- 1983: 2
- 1984: 1
- 1985: 3
- 1987: 1
- 1988: 5
- 1994: 1

## Most-cited predicates

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