510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050191Substantially Equivalent

Modification to Bd Facscanto System with Bd Facscanto Clinical Software

Becton Dickinson & Co, San Jose CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050191 is the FDA 510(k) clearance record for MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE, a class I device, cleared for Becton, Dickinson & CO on under FDA product code PER (Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis). FDA's definition for product code PER reads: "Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis". FDA records list 345 510(k) clearances for Becton, Dickinson & CO, from to . As of , FDA records show 4 recalls naming K050191.

Clearance record

Decision date
Received
(26 days to decision)
Product code
PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Regulation
21 CFR 862.2750
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Becton, Dickinson & CO 2350 Qume Dr., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PER

Trailing 12 months

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

FDA records show no clearances under product code PER in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PER, 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