510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162462Substantially Equivalent

AMICUS Separator System, AMICUS Separator System; Refurbished

Fresenius Kabi USA, LLC, Lake Zurich IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162462 is the FDA 510(k) clearance record for AMICUS Separator System, AMICUS Separator System; Refurbished, a class II device, cleared for Fresenius Kabi USA,Llc on under FDA product code GKT (Separator, Automated, Blood Cell, Diagnostic). FDA records list 5 510(k) clearances for Fresenius Kabi USA,Llc, from to . As of , FDA records show no recalls naming K162462.

Clearance record

Decision date
Received
(82 days to decision)
Product code
GKT Separator, Automated, Blood Cell, Diagnostic
Regulation
21 CFR 864.9245
Device class
Class II
Review panel
Hematology
Applicant
Fresenius Kabi USA,Llc Three Corporate Dr., Lake Zurich IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GKT

Trailing 12 months

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

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