# KHG: Whole Blood Hemoglobin Determination

- Device class: 2; regulation: 21 CFR 864.7500; FDA's rule: 510(k) required
- FDA decisions: 39
- 510(k) review time 2021–2025: median 493 days (middle half 493–493)
- 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)
- 1988: 1
- 1989: 2
- 1993: 1
- 1995: 1
- 1998: 1
- 2000: 2
- 2002: 1
- 2004: 1
- 2017: 1
- 2023: 1

## Most-cited predicates
- K973649: Hemosite Test System (1998), cited by 1
- K042379: Anemiapro Self-Screener (2004), cited by 1

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