510(k) · Cleared
ClearedAdvia 120 Hematology System, Cerebrospinal Fluid Method
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · GKL Counter, Cell, Automated (Particle Counter)
Cleared on Sep 11, 2002 as substantially equivalent to K003796 (Bayer Corp., 2001) after a 55-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Sep 11, 2002
- Review
- 55 days
- Class
- Class II
- Product code
- GKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003796 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003796 Advia 120 HematologyBayer Corp. · 2001
- This deviceK022331 Advia 120 Hematology System, Cerebrospinal Fluid MethodBayer Diagnostics Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003796 | Advia 120 Hematology | Bayer Corp. | 2001 | — |
| 0 (this device) | K022331 | Advia 120 Hematology System, Cerebrospinal Fluid Method | Bayer Diagnostics Corp. | 2002 | — |
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 |
|---|---|---|---|
| * | K003796 | Advia 120 HematologySummary page 1…on provides data supporting a substantially equivalent determination between the revised ADVIA 120 cerebrospinal fluid (CSF) method and the current ADVIA 120 CSF method (K003796). Intended Use The ADVIA 120 cerebrospinal fluid (CSF) cell count is intended to provide an in vitro diagnostic, quantitative de… | 2001 |
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?
- Its one ancestor has no recall.
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 cerebrospinal fluid (CSF) cell count is intended to provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens analyzed in the manual open tube mode. The ADVIA 120 provides leukocyte (WBC) and erythrocyte (REX) counts along with both absolute and proportional counts for the WBC differential.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022331: Advia 120 Hematology System, Cerebrospinal Fluid Method.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022331
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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