510(k) · Cleared
ClearedAdvia 60 Hematology Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · GKZ Counter, Differential Cell
Cleared on Sep 8, 2003 as substantially equivalent to K982802 (Bayer Corp., 1998) and 1 other predicate after a 24-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Sep 8, 2003
- Review
- 24 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K872166 (1987). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK872166 Facscan Flow Cytometer - Reticcount Reti. Enu. KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1987
- 1 generation backK961439 Abbott Cell-Dyn 4000 SystemAbbott Diagnostics · 1996 · Recalled
- This deviceK032524 Advia 60 Hematology AnalyzerBayer Healthcare, LLC · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872166 | Facscan Flow Cytometer - Reticcount Reti. Enu. Kit | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987 | — |
| −1 | K961439 | Abbott Cell-Dyn 4000 System | Abbott Diagnostics | 1996 | 7 |
| 0 (this device) | K032524 | Advia 60 Hematology Analyzer | Bayer Healthcare, LLC | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982802 | Bayer Advia 60 Hematology System (in Vitro Diagnostic System)Summary page 1…, ADVIA 60 with software version I.4. The ADVIA 60 with software version 1.6 is based on the same fundamental technology as the predicate device cleared to market under K982802. The Abbott Cell-Dyn 4000 (K961439) is also used as a predicate device to establish clinical accuracy of the ADVIA 60 with softw… | 1998 |
| * | K961439 | Abbott Cell-Dyn 4000 SystemSummary page 1…. The ADVIA 60 with software version 1.6 is based on the same fundamental technology as the predicate device cleared to market under K982802. The Abbott Cell-Dyn 4000 (K961439) is also used as a predicate device to establish clinical accuracy of the ADVIA 60 with software version 1.6. Intended Use For i… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
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?
For in-vitro diagnostic use in the quantitative determination of blood cells and hematologic parameters in whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032524: Advia 60 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/K032524
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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