510(k) · Cleared
ClearedHemocue WBC System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemocue AB · GKL Counter, Cell, Automated (Particle Counter)
Cleared on Oct 25, 2007 as substantially equivalent to K060656 (Sysmex America, Inc., 2006) after a 129-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Oct 25, 2007
- Review
- 129 days
- Class
- Class II
- Product code
- GKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060656 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK060656 Sysmex Automated Hematology Analyzer Models XS SeriesSysmex America, Inc. · 2006
- This deviceK071652 Hemocue WBC SystemHemocue AB · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060656 | Sysmex Automated Hematology Analyzer Models XS Series | Sysmex America, Inc. | 2006 | — |
| 0 (this device) | K071652 | Hemocue WBC System | Hemocue AB | 2007 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKL? 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060656 | Sysmex Automated Hematology Analyzer Models XS SeriesSummary page 1…substantial equivalence to the current legally marketed device: Sysmex XS-1I000i, Automated haematology analyzer (1K060656) and Manual light microscopic WBC method (class I exempt) 5.1 Device Description The system consist… | 2006 |
| * | — | Manual light microscopic WBC method Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All GKL devicesGKL Counter, Cell, Automated (Particle Counter): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GKL
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GKL
Too few GKL 510(k)s in any year since 2007 to give a median.
Recalls per year · GKL
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKL
1in 2025
MAUDE reports naming product code GKL, 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 | — | 1 | 25 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) count in capillary or venous whole blood. The HemoCue WBC system is for In Vitro Diagnostic use only. The HemoCue WBC Analyzer is only to be used with HemoCue WBC Microcuvettes. The HemoCue WBC system is indicated for use in clinical laboratories and for point-of-care settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071652 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071652: Hemocue WBC System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071652
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026