# K180615: AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Kabi USA,Llc
- Decided: Dec 4, 2018 after 271 days
- Product code: LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic)
- Device class: U
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K831004 (1983). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132429: Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set, Terumobct, Inc. (2013) Summary page 5.

## Most influential descendants
- K192150: AMICUS Separator System (2019), 1 descendant of its own
- K200530: AMICUS Separator System (2020), 0 descendants of its own

## Recalls of this device
- Feb 14, 2023 · Class II · Z-1254-2023: Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
- Feb 14, 2023 · Class II · Z-1255-2023: Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
- Feb 25, 2021 · Class II · Z-1345-2021: Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the 
- Feb 25, 2021 · Class II · Z-1344-2021: Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the 

## Indications for use
Depending on the AMICUS Separator System disposable used in the therapeutic apheresis procedure, the AMICUS Separator System has been cleared for the following: The AMICUS Separator System is an automated blood cell separator indicated to perform therapeutic plasma exchange (TPE). (K111702) The AMICUS Exchange Kit is indicated for use in Therapeutic Plasma Exchange (TPE). The kit is for use with the AMICUS separator. (K111702) The AMICUS Separator System is an automated blood component separator indicated to perform red blood cell exchange (RBCX), including Exchange and Depletion/Exchange procedures, for the transfusion management of sickle cell disease in adults and children. (K180615) The AMICUS Exchange Kit - Therapeutics is indicated for use in Therapeutic Plasma Exchange (TPE) and Red Blood Cell Exchange (RBCX). The kit is for use with the AMICUS separator. (K111702, K180615) The Waste Transfer Set is indicated for use in Red Blood Cell Exchange (RBCX). The set is for use with the AMICUS separator. (K180615) The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a Therapeutic Plasma Exchange (TPE) or Red Blood Cell Exchange (RBCX) therapeutic apheresis procedure. The set is for use with the AMICUS separator. (K111702, K180615)

Source page: https://510kreport.com/device/K180615
Methodology: https://510kreport.com/methodology