# K040725: BD Facscanto System

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Sep 10, 2004 after 172 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K925274 (1994). 3 ancestors in all.
4 later devices descend from it; 2 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)
- K973483: Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set, Becton Dickinson Immunocytometry Systems (1998) Summary page 1.

## Most influential descendants
- K141468: BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) (2015), 2 descendants of its own
- K062087: BD Facscanto II Flow Cytometer,  Model 338960; (5-3),  Model 339473; (4-2-2), Model 338962 (2006), 2 descendants of its own
- 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.

## Indications for use
Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse wash sample preparation method. Immunophenotyping of lymphocyte subsets including CD3+CD8 +, CD3+CD4 +, CD3-CD 16+ and/or CD56 +, CD3-CD19 +, and CD3 +.

Source page: https://510kreport.com/device/K040725
Methodology: https://510kreport.com/methodology