# KQG: Instrument, Coagulation

- Device class: 2; regulation: 21 CFR 864.5400; FDA's rule: 510(k) required
- FDA decisions: 14
- 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)
- 1977: 1
- 1979: 1
- 1982: 2
- 1985: 2
- 1986: 1
- 1990: 2
- 1999: 3
- 2002: 1
- 2005: 1

## Most-cited predicates
- K983475: Hemochron Response (1999), cited by 1

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