510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180615Substantially Equivalent

AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter

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

K180615 is the FDA 510(k) clearance record for AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter, cleared for Fresenius Kabi USA,Llc on under FDA product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic). FDA records list 5 510(k) clearances for Fresenius Kabi USA,Llc, from to . As of , FDA records show 4 recalls naming K180615.

Clearance record

Decision date
Received
(271 days to decision)
Product code
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Device class
Unclassified
Review panel
Unknown
Applicant
Fresenius Kabi USA,Llc Three Corporate Dr., Lake Zurich IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKN

Trailing 12 months

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

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