510(k) · Cleared
Recalled · Class II · 2017Coulter LH 750 Body Fluids Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · GKZ Counter, Differential Cell
Cleared on Apr 21, 2003 after a 55-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Apr 21, 2003
- Review
- 55 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK030606 Coulter LH 750 Body Fluids ApplicationBeckman Coulter, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK061616 Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK090346 Advia 2120/2120I Body FluidsSiemens Healthcare Diagnostics · 2010
- Descendant · 2 generations on · 0 of its ownK081930 Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK061574 Coulter LH 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK050057 Coulter LH 750 Hematology AnalyzerBeckman Coulter, Inc. · 2005 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K061616Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc. · 2006 · cites it directly1descendant
- K090346Advia 2120/2120I Body FluidsSiemens Healthcare Diagnostics · 2010 · cites it directly0descendants
- K081930Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2008 · 2 generations on0descendants
- K061574Coulter LH 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. · 2006 · cites it directly0descendants
- K050057Coulter LH 750 Hematology AnalyzerBeckman Coulter, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030606 | Coulter LH 750 Body Fluids Application | Beckman Coulter, Inc. | 2003 | — |
| +1 | K061616 | Coulter LH 780 Hematology Analyzer | Beckman Coulter, Inc. | 2006 | 7 |
| +1 | K090346 | Advia 2120/2120I Body Fluids | Siemens Healthcare Diagnostics | 2010 | — |
| +2 | K081930 | Unicel DXH 800 Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2008 | 29 |
| +1 | K061574 | Coulter LH 750 Hematology Analyzer, Model 6605632 | Beckman Coulter, Inc. | 2006 | — |
| +1 | K050057 | Coulter LH 750 Hematology Analyzer | Beckman Coulter, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
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 GKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Manual cell count method in a counting chamber by a skilled competent technician Named without a submission number |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2017 | Class II | Z-3113-2017 | Labeling Change Control | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061616 (Beckman Coulter, Inc., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, 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 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
The COULTER@LH 750 Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER@LH 750 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs). The system also provides an automated method for enumeration of RBCs and WBCs in body fluids.
Future commercialization will add ISOTONB 4 diluent /Lyse S 8 4 Lytic reagent to the indications for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030606 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030606: Coulter LH 750 Body Fluids Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030606
Report an extraction error
Are you the manufacturer?
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