510(k) · Cleared
Recalled · Class II · 2017Modification to Coulter LH 750 Hematology Analyzer, Model 6605632
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 Jul 29, 2002 as substantially equivalent to K011342 (Beckman Coulter, Inc., 2001) after a 26-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 29, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011342 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011342 Coulter LH 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. · 2001 · Recalled
- This deviceK022161 Modification to Coulter LH 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK032013 Coulter Act 5DIFF AL Hematology AnalyzerBeckman Coulter, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK042173 Coulter a T 5DIFF Cap Pierce (CP)Beckman Coulter, Inc. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011342 | Coulter LH 750 Hematology Analyzer, Model 6605632 | Beckman Coulter, Inc. | 2001 | 15 |
| 0 (this device) | K022161 | Modification to Coulter LH 750 Hematology Analyzer, Model 6605632 | Beckman Coulter, Inc. | 2002 | — |
| +1 | K032013 | Coulter Act 5DIFF AL Hematology Analyzer | Beckman Coulter, Inc. | 2003 | — |
| +2 | K042173 | Coulter a T 5DIFF Cap Pierce (CP) | Beckman Coulter, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K011342 | Coulter LH 750 Hematology Analyzer, Model 6605632 | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032013 | Coulter Act 5DIFF AL Hematology Analyzer | 2003 | 1 |
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. |
| Nov 8, 2002 | Not classified | Z-0415-03 | Other | Software vote out logic changed. Erroneous white blood cell counts. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Analyze; 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).
Future commercialization will add ISOTONB 4 diluent /Lyse S@4 Lytic reagent to the indications for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022161: Modification to Coulter LH 750 Hematology Analyzer, Model 6605632.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022161
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