# K181751: HemoCue Hb 801 System

- Pathway: 510(k) (Traditional)
- Applicant: Hemocue AB
- Decided: Feb 1, 2019 after 214 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: 2 generations back to K032203 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061047: Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801, Hemocue AB (2006) Summary page 7.

## Most influential descendants
- K201217: HemoCue Hb 301 System (2020), 0 descendants of its own

## Indications for use
The HemoCue® Hb 801 System is intended for the quantitative determination of hemoglobin in capillary or venous whole blood (K2EDTA and Li-Heparin) in point-of-care settings. The HemoCue® Hb 801 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old. The HemoCue® Hb 801 System is for professional in vitro diagnostic use only.

Source page: https://510kreport.com/device/K181751
Methodology: https://510kreport.com/methodology