510(k) · Cleared
ClearedModification to Bayer 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 · GKL Counter, Cell, Automated (Particle Counter)
Cleared on Dec 7, 2005 as substantially equivalent to K042251 (Bayer Healthcare, LLC, 2004) after a 167-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Dec 7, 2005
- Review
- 167 days
- Class
- Class II
- Product code
- GKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971998 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK971998 Advia 120 Hematology System, in Vitro Diagnostic SystemBayer Corp. · 1997 · Recalled
- 1 generation backK042251 Bayer Advia 2120 Hematology Analyzer with Autoslide SystemBayer Healthcare, LLC · 2004
- This deviceK051693 Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide…Bayer Healthcare, LLC · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971998 | Advia 120 Hematology System, in Vitro Diagnostic System | Bayer Corp. | 1997 | 2 |
| −1 | K042251 | Bayer Advia 2120 Hematology Analyzer with Autoslide System | Bayer Healthcare, LLC | 2004 | — |
| 0 (this device) | K051693 | Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide System | Bayer Healthcare, LLC | 2005 | — |
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 |
|---|---|---|---|
| * | K042251 | Bayer Advia 2120 Hematology Analyzer with Autoslide 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: K042251 nRBC counts are performed by manual methods that are well established as reference methods in clinical laboratories and consiste… | 2004 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K042251.
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® 2120 Nucleated Red Blood Cell (nRBC) method is intended to provide an in vitro diagnostic, quantitative determination of nucleated red blood cells in peripheral whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051693: Modification to 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/K051693
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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