510(k) · Cleared
ClearedBayer Advia 60 Hematology System (in Vitro Diagnostic System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · GKZ Counter, Differential Cell
Cleared on Sep 22, 1998 after a 43-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Sep 22, 1998
- Review
- 43 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK982802 Bayer Advia 60 Hematology System (in Vitro Diagnostic System)Bayer Corp. · 1998
- Descendant · cites it directly · 0 of its ownK032524 Advia 60 Hematology AnalyzerBayer Healthcare, LLC · 2003
Most influential descendants
Showing 1 of 1 · See all- K032524Advia 60 Hematology AnalyzerBayer Healthcare, LLC · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982802 | Bayer Advia 60 Hematology System (in Vitro Diagnostic System) | Bayer Corp. | 1998 | — |
| +1 | K032524 | Advia 60 Hematology Analyzer | Bayer Healthcare, LLC | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | — | ABX MICROS Hematology System Named without a submission number |
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 |
|---|---|---|---|
| K032524 | Advia 60 Hematology Analyzer | 2003 | 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?
- Of its descendants, K032524 (Bayer Healthcare, LLC, 2003) has gone furthest, with 0 descendants of its own.
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 Bayer ADVIA 60 is an automated in vitro diagnostic hematology analyzer capable of determining the following eighteen (18) hematological parameters: white blood cells (leukocytes) WBC red blood cells (erythrocytes) RBC hemoglobin HGB hematocrit HCT mean corpuscular volume MCV mean corpuscular hemoglobin MCH mean corpuscular hemoglobin concentration MCHC red blood cell distribution width RDW platelets PLT mean platelet volume MPV lymphocyte (number)…
Read the full statement (141 words)
The Bayer ADVIA 60 is an automated in vitro diagnostic hematology analyzer capable of determining the following eighteen (18) hematological parameters:
white blood cells (leukocytes) WBC
red blood cells (erythrocytes) RBC
hemoglobin HGB
hematocrit HCT
mean corpuscular volume MCV
mean corpuscular hemoglobin MCH
mean corpuscular hemoglobin concentration MCHC
red blood cell distribution width RDW
platelets PLT
mean platelet volume MPV
lymphocyte (number) #LYM
lymphocyte (percent of WBC) %LYM
monocyte (number) #MON
monocyte-(percent of WBC) %MON
granulocyte (number) #GRA
granulocyte (percent of WBC) %GRA
The ADVIA 60 Hematology Analyzer can be programmed to printout any of the following groups of parameters:
16 parameters
8 parameters (WBC (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, and PLT)
5 parameters (WBC, RBC, MPV, HGB, HCT)
Only the eight (8) and sixteen (16) parameter printout will be made available for diagnostic use in the United States.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982802: Bayer Advia 60 Hematology System (in Vitro Diagnostic System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982802
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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