# K162462: AMICUS Separator System, AMICUS Separator System; Refurbished

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Kabi USA,Llc
- Decided: Nov 23, 2016 after 82 days
- Product code: GKT (Separator, Automated, Blood Cell, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 864.9245
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K811078 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141019: Amicus Separator System/ Amicus Seperator System;Refurbished, Fenwal, Inc. (2014) Summary page 7.

## Cited in the summary but kept off the family tree
- K150357: Reprocessed Electrophysiology Diagnostic Catheters, Sterilmed, Inc. (2015). The summary prints BK150357, a CBER number, which our reading took as K150357, FDA’s number for Reprocessed Electrophysiology Diagnostic Catheters (Sterilmed, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “AMICUS Separator System”. Kept off the family tree. Summary page 7.

## Indications for use
The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter. Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect: » Platelets Pheresis, Leukocytes Reduced (single, double, or triple units) » Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double or triple units) « Red Blood Cells, Leukocytes Reduced (by apheresis) » Mononuclear Cells * Plasma o Fresh Frozen Plasma » Must be prepared and placed in a freezer at -18° C or colder within 8 hours after phlebotomy. o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) * Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at -18° C or colder within 24 hours after phlebotomy. » Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24) » Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy. » Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. o Source Plasma Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Pheresis, Platelet Additive Solution (InterSol) (single, double, or triple units). The AMICUS platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to 7 days. Additionally, for platelet units stored past 5 days and through 7 days, every product must be tested with a bacterial device cleared by FDA and labeled as a “safety measure.”

Source page: https://510kreport.com/device/K162462
Methodology: https://510kreport.com/methodology