510(k) · Decided
DecidedDxH 520 Hematology Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter · GKZ Counter, Differential Cell
Cleared on Mar 1, 2019 as substantially equivalent to K140911 (Beckman Coulter, Inc., 2014) after a 270-day review. Its family tree reaches back 2 generations to 2013. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 1, 2019
- Review
- 270 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K120771 (2013). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK120771 Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2013 · Recalled
- 1 generation backK140911 Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH…Beckman Coulter, Inc. · 2014 · Recalled (Class I)
- This deviceK181475 DxH 520 Hematology InstrumentBeckman Coulter · 2019
Class I recalls in this family
- K140911 Unicel DXH 800 Coulter Cellular Analysis System/…direct predicate · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K120771 | Unicel DXH 800 Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2013 | 11 |
| −1 | K140911 | Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer… | Beckman Coulter, Inc. | 2014 | Class I |
| 0 (this device) | K181475 | DxH 520 Hematology Instrument | Beckman Coulter | 2019 | — |
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? (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 |
|---|---|---|---|
| * | K140911 | Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter…Summary page 6…Classification 21 CFR Number Cleared Code UniCel® DxH 800 Coulter® Cellular K140911 09/05/2014 Class II 864.5220 GKZ Analysis System Manually prepared blood films per the manual wedge- pull film techn… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K140911.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 DxH 520 is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories and physician's office laboratories. It is used to identify the normal patient with normal system-generated parameters from patients with abnormal parameters and/or flags that require additional studies. The DxH 520 identifies and enumerates the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV…
Read the full statement (131 words)
The DxH 520 is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories and physician's office laboratories. It is used to identify the normal patient with normal system-generated parameters from patients with abnormal parameters and/or flags that require additional studies.
The DxH 520 identifies and enumerates the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, LY%, LY#, MO%, MO#, NE%, NE#, EO%, EO#, BA%, BA# in whole blood samples (venous and capillary) collected in K2EDTA and K3EDTA anticoagulants, and prediluted whole blood.
The instrument is for use in adult and pediatric populations, including neonates.
All numerical results reported for Basophil count and percent values must be reflexed for manual microscopy or followed up for additional testing based on the laboratory’s SOP.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181475: DxH 520 Hematology Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181475
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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