# K032203: Hemocue Hemoglobin 201 + System Article 121704

- Pathway: 510(k) (Special)
- Applicant: Hemocue, Inc.
- Decided: Aug 25, 2003 after 38 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061047: Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801 (2006), 4 descendants of its own
- K181751: HemoCue Hb 801 System (2019), 1 descendant of its own
- K221508: AnemoCheck Home (2023), 0 descendants of its own
- K201217: HemoCue Hb 301 System (2020), 0 descendants of its own
- K182298: hemochroma PLUS System (2018), 0 descendants of its own

## Recalls of this device
- Jul 25, 2013 · Class II · Z-0101-2014: HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.

## Indications for use
Quantitative determination of hemoglobin in capillary, venous and arterial whole blood. The HemoCueB Hb 201 Microcuvettes are intended for use in the HemoCueB Hb 20 1' analyzer. The HemoCue 20 1 system is used for the quantitative determination of hemoglobin in blood using a specially designed analyzer, the HemoCue Hb 20 1' analyzer, and specially designed microcuvettes the HemoCue Hb 201 Microcuvettes. The HemoCue Hb 201' analyzer is only to be used with HemoCue Hb 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 20 1' analyzer is only to be used together with HemoCue Hb 20 1 microcuvettes. The use of any other device in the HemoCue Hb 201' analyzer except the HemoCue Hb 201 microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequences. The HemoCue Hb 201 microcuvettes are for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K032203
Methodology: https://510kreport.com/methodology