510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K141468Substantially Equivalent

BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)

Becton, Dickinson and Company, BD Biosciences, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141468 is the FDA 510(k) clearance record for BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration), a class II device, cleared for Bd Biosciences on under FDA product code OYE (Flow Cytometric Reagents And Accessories.). FDA's definition for product code OYE reads: "To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level...". FDA records list 10 510(k) clearances for BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES, from to . As of , FDA records show no recalls naming K141468.

Clearance record

Decision date
Received
(269 days to decision)
Product code
OYE Flow Cytometric Reagents And Accessories.
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Bd Biosciences 2350 Qume Dr., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYE

Trailing 12 months

FDA records hold no clearances under product code OYE in the trailing twelve months.

FDA records show no clearances under product code OYE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OYE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260