# K042251: Bayer Advia 2120 Hematology Analyzer with Autoslide System

- Pathway: 510(k) (Special)
- Applicant: Bayer Healthcare, LLC
- Decided: Sep 17, 2004 after 28 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971998 (1997). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971998: Advia 120 Hematology System, in Vitro Diagnostic System, Bayer Corp. (1997) Summary page 1.

## Most influential descendants
- K102644: Advia 2120 with Autoslide System, and Advia 2120I (2011), 1 descendant of its own
- K163215: AnemoCheck (2017), 0 descendants of its own
- K162977: ADVIA 2120i, ADVIA 2120 (2017), 0 descendants of its own
- K051693: Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide System (2005), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K042251
Methodology: https://510kreport.com/methodology