510(k) · Cleared
Recalled · Class II · 2013Advia 120 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. · GKL Counter, Cell, Automated (Particle Counter)
Cleared on Aug 29, 1997 after a 91-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 29, 1997
- Review
- 91 days
- Class
- Class II
- Product code
- GKL
- Recalls
- 2
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK971998 Advia 120 Hematology System, in Vitro Diagnostic SystemBayer Corp. · 1997
- Descendant · cites it directly · 4 of its ownK042251 Bayer Advia 2120 Hematology Analyzer with Autoslide SystemBayer Healthcare, LLC · 2004
- Descendant · 2 generations on · 1 of its ownK102644 Advia 2120 with Autoslide System, and Advia 2120ISiemens Healthcare Diagnostics · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK163215 AnemoCheckSanguina, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK162977 ADVIA 2120i, ADVIA 2120Siemens Healthcare Diagnostics · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK051693 Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide…Bayer Healthcare, LLC · 2005
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K042251Bayer Advia 2120 Hematology Analyzer with Autoslide SystemBayer Healthcare, LLC · 2004 · cites it directly4descendants
- K102644Advia 2120 with Autoslide System, and Advia 2120ISiemens Healthcare Diagnostics · 2011 · 2 generations on1descendant
- K163215AnemoCheckSanguina, LLC · 2017 · 2 generations on0descendants
- K162977ADVIA 2120i, ADVIA 2120Siemens Healthcare Diagnostics · 2017 · 3 generations on0descendants
- K051693Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide SystemBayer Healthcare, LLC · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971998 | Advia 120 Hematology System, in Vitro Diagnostic System | Bayer Corp. | 1997 | — |
| +1 | K042251 | Bayer Advia 2120 Hematology Analyzer with Autoslide System | Bayer Healthcare, LLC | 2004 | — |
| +2 | K102644 | Advia 2120 with Autoslide System, and Advia 2120I | Siemens Healthcare Diagnostics | 2011 | 21 |
| +2 | K163215 | AnemoCheck | Sanguina, LLC | 2017 | — |
| +3 | K162977 | ADVIA 2120i, ADVIA 2120 | Siemens Healthcare Diagnostics | 2017 | 20 |
| +2 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 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 GKL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Technicon H-3 RTC Named without a submission number |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2013 | Class II | Z-2114-2013 | Equipment maintenance | The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is… |
| Mar 16, 2006 | Not classified | Z-1376-06 | Other | The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso cytogram. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042251 (Bayer Healthcare, LLC, 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GKL devicesGKL Counter, Cell, Automated (Particle Counter): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKL
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GKL
Too few GKL 510(k)s in any year since 2007 to give a median.
Recalls per year · GKL
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKL
1in 2025
MAUDE reports naming product code GKL, 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 | 1 | — | 1 | 25 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ADVIA 120 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for in vitro diagnostic use in clinical laboratories.
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/K971998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971998: Advia 120 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/K971998
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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