# GKF: Instrument, Hematocrit, Automated

- Device class: 2; regulation: 21 CFR 864.5600; FDA's rule: 510(k) required
- FDA decisions: 15
- 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)
- 1981: 1
- 1986: 1
- 1987: 2
- 1988: 1
- 1990: 1
- 1992: 2
- 1995: 1
- 1998: 3
- 1999: 1
- 2016: 1

## Most-cited predicates
- K160415: GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) (2016), cited by 1
- K981426: Stat Profile Ultra F,G,H,I,J,K, and L Analyzers (1998), cited by 1

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