510(k) · Cleared
Recalled · Class II · 2021ADVIA 2120i, ADVIA 2120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · GKZ Counter, Differential Cell
Cleared on Aug 11, 2017 as substantially equivalent to K102644 (Siemens Healthcare Diagnostics, 2011) after a 289-day review. Its family tree reaches back 3 generations to 1997. It has been recalled 20 times.
- Decided
- Aug 11, 2017
- Review
- 289 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 20
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971998 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK971998 Advia 120 Hematology System, in Vitro Diagnostic SystemBayer Corp. · 1997 · Recalled
- 2 generations backK042251 Bayer Advia 2120 Hematology Analyzer with Autoslide SystemBayer Healthcare, LLC · 2004
- 1 generation backK102644 Advia 2120 with Autoslide System, and Advia 2120ISiemens Healthcare Diagnostics · 2011 · Recalled
- This deviceK162977 ADVIA 2120i, ADVIA 2120Siemens Healthcare Diagnostics · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971998 | Advia 120 Hematology System, in Vitro Diagnostic System | Bayer Corp. | 1997 | 2 |
| −2 | 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 |
| 0 (this device) | K162977 | ADVIA 2120i, ADVIA 2120 | Siemens Healthcare Diagnostics | 2017 | — |
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 |
|---|---|---|---|
| * | K102644 | Advia 2120 with Autoslide System, and Advia 2120ISummary page 4…524-2582 Fax: (914) 524-3579) Regulatory Information: The ADVIA®2120i is a class 2 analyzer that produces no PMA results. Predicate Devices: ADVIA®2120 cleared in k102644 ADVIA®2120i cleared in k102644 Device Description: The ADVIA 2120i (RoHS/REACH compliant) is a modification of the ADVIA 2120i… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2021 | Class II | Z-1390-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1395-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1393-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1404-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1400-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1403-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1394-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1396-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1386-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1399-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1402-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1398-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1392-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1397-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1387-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1388-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1401-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1389-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1391-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Mar 5, 2021 | Class II | Z-1405-2021 | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
The 5 latest of 20 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 ADVIA 2120 and ADVIA 2120i with auto slide are quantitative, automated hematology analyzers that provide the following information for in vitro diagnostic use in clinical laboratories: * A complete blood count (CBC) consisting of WBC, RBC, Hgb, CN-Free Hgb, Calculated Hgb, MCV, Het, MCH, MCHC, CHCM, RDW, HDW, CH, PIt, MPV. * A leukocyte differential count consisting of: Neut (%/#), Lymph (%/#), Mono (%/#), Eos (%/#) Baso (%/#), LUC (%/#). * A…
Read the full statement (182 words)
The ADVIA 2120 and ADVIA 2120i with auto slide are quantitative, automated hematology analyzers that provide the following information for in vitro diagnostic use in clinical laboratories:
* A complete blood count (CBC) consisting of WBC, RBC, Hgb, CN-Free Hgb, Calculated Hgb, MCV, Het, MCH, MCHC, CHCM, RDW, HDW, CH, PIt, MPV.
* A leukocyte differential count consisting of: Neut (%/#), Lymph (%/#), Mono (%/#), Eos (%/#) Baso (%/#), LUC (%/#).
* A reticulocyte analysis consisting of Retic (%/#), MCVg, MCVr, CHCMg, CHCMr, CHg, CHr.
» A nucleated red blood cell count consisting of NRBC (%/#).
* Enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens.
Note: Above measurands are determined (in whole blood, pleural, peritoneal, or peritoneal dialysis specimens) with K2 and/or K3 EDTA anti-coagulants.
* Quantitative determination of blood cells in Cerebrospinal Fluid (CSF) consisting of WBC, RBC, Neut (%/#), Lymph (%/#), Mono (%/#), MN (%/#), PMN (%/#).
In addition, the system provides the added capability to automatically prepare and stain high quality blood smears on a glass microscope slide.
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/K162977 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162977: ADVIA 2120i, ADVIA 2120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162977
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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