# GKT: Separator, Automated, Blood Cell, Diagnostic

- Device class: 2; regulation: 21 CFR 864.9245; FDA's rule: 510(k) required
- FDA decisions: 10
- Recalls: 0 (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: 2
- 1979: 3
- 1980: 1
- 1982: 2
- 2016: 1
- 2020: 1

## Most-cited predicates

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