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
K904795Substantially Equivalent

Facsprep Robotic Sample Preparation System

BD Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904795 is the FDA 510(k) clearance record for FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM, a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code GKH (Apparatus, Automated Blood Cell Diluting). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K904795.

Clearance record

Decision date
Received
(73 days to decision)
Product code
GKH Apparatus, Automated Blood Cell Diluting
Regulation
21 CFR 864.5240
Device class
Class I
Review panel
Hematology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1 Becton Dr., Franklin Lakes NJ
Third party review
No

Clearances, product code GKH

Trailing 12 months

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

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