K180615 - AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter (FDA 510(k) Clearance)

K180615 is an FDA 510(k) clearance for the AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer S.... Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Fresenius Kabi USA,Llc (Lake Zurich, US). The FDA issued a Cleared decision on December 4, 2018 after a review of 271 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.