BD FACSCANTO SYSTEM— 510(k) K040725

Clearance details

Applicant

Becton Dickinson Immunocytometry Systems

Product code

Code GKZ

Device class

Class 2

Regulation

21 CFR 864.5220

Advisory panel

Hematology

Date received

2004-03-22

Decision date

2004-09-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Jose, CA, US

• K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers2026-05-27
• K243348 — Athelas Home2026-02-06
• K251249 — Tru Hematology Test2026-01-16
• K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer2025-06-25
• K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer2025-06-25

• K040026 — BD FACS 7-COLOR SETUP BEADS2004-09-10
• K980858 — MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION1998-05-22
• K974360 — MULTITEST CD3/CD8/CD45/CD41998-03-11
• K973483 — FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET1998-02-17
• K971205 — TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES1997-12-01

Malfunction

1,205

Total

1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2090-2015 — BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.Class III·Terminated·BD Biosciences, Systems & Reagents·20150615

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040725.