# KRY: Calibrator For Platelet Counting

- Device class: 2; regulation: 21 CFR 864.8175; FDA's rule: 510(k) exempt
- FDA decisions: 8
- Recalls: 1 (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)
- 1978: 3
- 1982: 1
- 1984: 1
- 1985: 2
- 1987: 1

## Most-cited predicates

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