# K051693: Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 7, 2005 after 167 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971998 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042251: Bayer Advia 2120 Hematology Analyzer with Autoslide System, Bayer Healthcare, LLC (2004) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K051693
Methodology: https://510kreport.com/methodology