# K971998: Advia 120 Hematology System, in Vitro Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Aug 29, 1997 after 91 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Technicon H-3 RTC: named in the summary without a submission number

## Most influential descendants
- K042251: Bayer Advia 2120 Hematology Analyzer with Autoslide System (2004), 4 descendants of its own
- 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

## Recalls of this device
- Jun 26, 2013 · Class II · Z-2114-2013: The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the 
- Mar 16, 2006 · Not classified · Z-1376-06: The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso cytogram

## Indications for use
The ADVIA 120 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for in vitro diagnostic use in clinical laboratories.

Source page: https://510kreport.com/device/K971998
Methodology: https://510kreport.com/methodology