# K062087: BD Facscanto II Flow Cytometer,  Model 338960; (5-3),  Model 339473; (4-2-2), Model 338962

- Pathway: 510(k) (Special)
- Applicant: Bd Biosciences
- Decided: Sep 14, 2006 after 52 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K925274 (1994). 5 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K041074: BD Facscanto with BD Facsanto Software, Bd Biosciences (2004) Summary page 1.
- K040725: BD Facscanto System, Becton Dickinson Immunocytometry Systems (2004) Summary page 1.

## Most influential descendants
- K170974: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK (2017), 1 descendant of its own
- K201814: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit (2020), 0 descendants of its own

## Recalls of this device
- Jun 15, 2015 · Class III · Z-2090-2015: Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and I
- Dec 21, 2007 · Not classified · Z-1530-2008: Values might not update in statistics views after certain functions are performed in a worksheet.
- Apr 5, 2007 · Not classified · Z-1525-2008: When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.

## Indications for use
Immunophenotyping in clinical laboratories, using previously cleared in vitro diagnostic assays for flow cytometry. Identification and enumeration of lymphocyte subsets in human cells in suspension. For in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant II.

Source page: https://510kreport.com/device/K062087
Methodology: https://510kreport.com/methodology