510(k) · Cleared
ClearedBayer Advia 2120 Hematology Analyzer with Autoslide System
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 17, 2004 as substantially equivalent to K971998 (Bayer Corp., 1997) after a 28-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Sep 17, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971998 (1997). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK971998 Advia 120 Hematology System, in Vitro Diagnostic SystemBayer Corp. · 1997 · Recalled
- This deviceK042251 Bayer Advia 2120 Hematology Analyzer with Autoslide SystemBayer Healthcare, LLC · 2004
- Descendant · cites it directly · 1 of its ownK102644 Advia 2120 with Autoslide System, and Advia 2120ISiemens Healthcare Diagnostics · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK163215 AnemoCheckSanguina, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK162977 ADVIA 2120i, ADVIA 2120Siemens Healthcare Diagnostics · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK051693 Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide…Bayer Healthcare, LLC · 2005
Most influential descendants
Showing 4 of 4 · See all- K102644Advia 2120 with Autoslide System, and Advia 2120ISiemens Healthcare Diagnostics · 2011 · cites it directly1descendant
- K163215AnemoCheckSanguina, LLC · 2017 · cites it directly0descendants
- K162977ADVIA 2120i, ADVIA 2120Siemens Healthcare Diagnostics · 2017 · 2 generations on0descendants
- K051693Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide SystemBayer Healthcare, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971998 | Advia 120 Hematology System, in Vitro Diagnostic System | Bayer Corp. | 1997 | 2 |
| 0 (this device) | K042251 | Bayer Advia 2120 Hematology Analyzer with Autoslide System | Bayer Healthcare, LLC | 2004 | — |
| +1 | K102644 | Advia 2120 with Autoslide System, and Advia 2120I | Siemens Healthcare Diagnostics | 2011 | 21 |
| +1 | K163215 | AnemoCheck | Sanguina, LLC | 2017 | — |
| +2 | K162977 | ADVIA 2120i, ADVIA 2120 | Siemens Healthcare Diagnostics | 2017 | 20 |
| +1 | K051693 | Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide System | Bayer Healthcare, LLC | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K971998 | Advia 120 Hematology System, in Vitro Diagnostic SystemSummary page 1…matology complete blood cell counter (§ 864.5200), differential cell counter (§ 864.5220) Classification number: 21 CFR Parts 864.5200, 864.5220, Class II 510(k) Number: K971998 3. Device Information Proprietary Name: Bayer ADVIA 2120 Hematology Analyzer with Autoslide System Common name: Automated Hemat… | 1997 |
| † | K022331 | Advia 120 Hematology System, Cerebrospinal Fluid Method | 2002 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 2120 Hematology System with Autoslide is a quantitative, automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for in vitro diagnostic use in clinical laboratories. In addition, the system provides the added capability to automatically prepare and stain high-quality blood smears on a microscope slide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042251: Bayer Advia 2120 Hematology Analyzer with Autoslide System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042251
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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