510(k) · Cleared
Recalled · Class II · 2025UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
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 5, 2024 as substantially equivalent to K193124 (Beckman Coulter, 2020) and 1 other predicate after a 157-day review. Its family tree reaches back 5 generations to 1991. 1 of the 14 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times.
- Decided
- Jul 5, 2024
- Review
- 157 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K912133 (1991). 13 ancestors in all, the oldest K885028 (1989). No later device cites it as a predicate yet. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK912133 PX Coulter (R) Cell ControlCoulter Electronics, Inc. · 1991
- 4 generations backK060464 Coulter 5C Cell ControlBeckman Coulter, Inc. · 2006
- 3 generations backK081822 Coulter 6C Cell Control, Models 628027 & A59925Beckman Coulter, Inc. · 2009
- 2 generations backK181599 Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator…Beckman Coulter · 2019
- 1 generation backK193124 Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter · 2020 · Recalled
- This deviceK240252 UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH…Beckman Coulter, Inc. · 2024
Class I recalls in this family
- K140911 Unicel DXH 800 Coulter Cellular Analysis System/…2 generations back · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912133 | PX Coulter (R) Cell Control | Coulter Electronics, Inc. | 1991 | — |
| −4 | K060464 | Coulter 5C Cell Control | Beckman Coulter, Inc. | 2006 | — |
| −3 | K081822 | Coulter 6C Cell Control, Models 628027 & A59925 | Beckman Coulter, Inc. | 2009 | — |
| −2 | K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | Beckman Coulter | 2019 | — |
| −1 | K193124 | Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter | 2020 | 1 |
| 0 (this device) | K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer… | Beckman Coulter, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2016 | 3 | 0 |
| 2017 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K193124 | Unicel DxH 800 Coulter Cellular Analysis SystemSummary page 4…807.92 (a)(3): Identification of the Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K193124 UniCel DxH 800 Coulter Cellular Analysis System with Early GKZ Sepsis Indicator Application K16… | 2020 |
| * | K162414 | UniCel DxH SlideMaker Stainer Coulter Cellular Analysis SystemSummary page 4…is listed first) Product Code K193124 UniCel DxH 800 Coulter Cellular Analysis System with Early GKZ Sepsis Indicator Application K162414 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System GKZ 807.92 (a)(4): Device Description Summary The Uni… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2025 | Class II | Z-2573-2025 | Component change control | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. |
| Aug 13, 2025 | Class II | Z-2572-2025 | Component change control | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K140911Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter Cellular Analysis…Beckman Coulter, Inc. · 2014 · 2 generations back · ◆ in the 2014 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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 UniCel DxH 900/DxH 690T Coulter Cellular Analysis System is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 900/DxH 690T analyzer identifies and enumerates the following parameters: • Whole Blood (Venous or Capillary): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%…
Read the full statement (149 words)
The UniCel DxH 900/DxH 690T Coulter Cellular Analysis System is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
The DxH 900/DxH 690T analyzer identifies and enumerates the following parameters:
• Whole Blood (Venous or Capillary): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF
• Pre-Diluted Whole Blood (Venous or Capillary): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV
• Body Fluids (cerebrospinal, serous or synovial): TNC and RBC
The UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240252: UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240252
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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