510(k) · Cleared
ClearedCoulter Act 5DIFF AL Hematology Analyzer
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 24, 2003 as substantially equivalent to K030291 (Beckman Coulter, Inc., 2003) and 1 other predicate after a 24-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Jul 24, 2003
- Review
- 24 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011342 (2001). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011342 Coulter LH 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. · 2001 · Recalled
- 1 generation backK022161 Modification to Coulter LH 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. · 2002 · Recalled
- This deviceK032013 Coulter Act 5DIFF AL Hematology AnalyzerBeckman Coulter, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK042173 Coulter a T 5DIFF Cap Pierce (CP)Beckman Coulter, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K042173Coulter a T 5DIFF Cap Pierce (CP)Beckman Coulter, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011342 | Coulter LH 750 Hematology Analyzer, Model 6605632 | Beckman Coulter, Inc. | 2001 | 15 |
| −1 | K022161 | Modification to Coulter LH 750 Hematology Analyzer, Model 6605632 | Beckman Coulter, Inc. | 2002 | 2 |
| 0 (this device) | K032013 | Coulter Act 5DIFF AL Hematology Analyzer | Beckman Coulter, Inc. | 2003 | — |
| +1 | K042173 | Coulter a T 5DIFF Cap Pierce (CP) | Beckman Coulter, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042173 | Coulter a T 5DIFF Cap Pierce (CP) | 2004 | 0 |
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?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K042173 (Beckman Coulter, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030291.
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 ACTM5diff AL Hematology Analyzer is a quantitative,
automated hematology Analyzer and leukocyte differential counter For In Vitro
Diagnostic Use in clinical laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032013: Coulter Act 5DIFF AL Hematology Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032013
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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