# GKR: System, Hemoglobin, Automated

- Device class: 2; regulation: 21 CFR 864.5620; FDA's rule: 510(k) required
- FDA decisions: 39
- Recalls: 3 (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)
- 2004: 1
- 2006: 1
- 2008: 1
- 2009: 1
- 2011: 1
- 2013: 2
- 2017: 1
- 2018: 2
- 2019: 1
- 2020: 2

## Most-cited predicates
- K945677: IL682, CO-Oximeter (1995), cited by 3
- K032203: Hemocue Hemoglobin 201 + System Article 121704 (2003), cited by 3
- K061047: Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801 (2006), cited by 3
- K031898: Ekf Diagnostic Hemo Control Hemoglobin Measurement System (2003), cited by 2
- K081719: Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System (2008), cited by 2
- K020616: Bayer Rapidpoint 405 System (2002), cited by 1
- K041234: Hemocue Hemoglobin 201DM Analyzing System (2004), cited by 1
- K032482: Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System (2003), cited by 1
- K181751: HemoCue Hb 801 System (2019), cited by 1

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