# K201217: HemoCue Hb 301 System

- Pathway: 510(k) (Traditional)
- Applicant: Hemocue AB
- Decided: Aug 4, 2020 after 90 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K032203 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181751: HemoCue Hb 801 System, Hemocue AB (2019) Summary page 7.

## Indications for use
The HemoCue® Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings. The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old in primary care setting. The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults in blood donation setting. The HemoCue® Hb 301 System is for professional in vitro diagnostic use only.

Source page: https://510kreport.com/device/K201217
Methodology: https://510kreport.com/methodology