510(k) · Cleared
Recalled · 2010Clinical Laboratory Analyzing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemocue, Inc. · LFR Glucose Dehydrogenase, Glucose
Cleared on May 20, 2004 after a 10-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- May 20, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- LFR
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2010 | Not classified | Z-1848-2011 | Process control | 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 of the analyzer. Possible incorrect… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 2025
MAUDE reports naming product code LFR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 3 | 23,819 |
| 2008 | 0 | — | 1 | 6,584 |
| 2009 | 1 | — | 4 | 10,823 |
| 2010 | 0 | — | 0 | 4,865 |
| 2011 | 6 | 296 | 1 | 3,802 |
| 2012 | 13 | 152 | 1 | 3,341 |
| 2013 | 3 | 212 | 0 | 3,821 |
| 2014 | 3 | 161 | 0 | 3,960 |
| 2015 | 1 | — | 0 | 3,366 |
| 2016 | 0 | — | 0 | 2,145 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 108 |
| 2019 | 0 | — | 0 | 108 |
| 2020 | 0 | — | 0 | 132 |
| 2021 | 0 | — | 0 | 164 |
| 2022 | 0 | — | 0 | 101 |
| 2023 | 0 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 171 |
| 2025 | 0 | — | 0 | 827 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 DM 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. The reagents/microcuvettes and the analyzer form an analytical system. The…
Read the full statement (124 words)
Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 DM 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.
The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Glucose 201 DM Analyzer is only to be used with HemoCue Glucose 201 Microcuvettes. The use of any other device in the HemoCue Glucose 201 DM Analyzer except the HemoCue Glucose 201 Microcuvettes is neither supported not recommended by HemoCue, and could give erroneous results with serious clinical consequences.
The HemoCue Glucose 201 Microcuvettes are for in vitro use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041230 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041230: Clinical Laboratory Analyzing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041230
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026