# K041234: Hemocue Hemoglobin 201DM Analyzing System

- Pathway: 510(k) (Special)
- Applicant: Hemocue, Inc.
- Decided: Jun 10, 2004 after 31 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K121752: Avie Total HB Test System (2013), 0 descendants of its own

## Recalls of this device
- Oct 7, 2010 · Not classified · Z-1849-2011: Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which are all related to the optronic performance 

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

Source page: https://510kreport.com/device/K041234
Methodology: https://510kreport.com/methodology