# K020935: Hemocue Glucose 201 System, Article Number 120706

- Pathway: 510(k) (Special)
- Applicant: Hemocue, Inc.
- Decided: Apr 3, 2002 after 12 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 4 (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
- K060765: Hemocue Glucose 201 RT Analyzer MDL 120731, Hemocue Glucose 201 RT Microcurettes MDL 110712 (2006), 0 descendants of its own

## Recalls of this device
- May 12, 2025 · Class II · Z-2070-2025: Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at th
- Oct 20, 2014 · Class II · Z-0873-2015: Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer w
- Jul 15, 2013 · Class II · Z-2190-2013: During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
- May 30, 2011 · Not classified · Z-0824-2012: A recall was initiated because Hemocue confirmed that the package insert for Hemocue Glucose 201 Microcuvettes had errors in two sections.

## Indications for use
Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue® Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

Source page: https://510kreport.com/device/K020935
Methodology: https://510kreport.com/methodology