# K111702: Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe

- Pathway: 510(k) (Traditional)
- Applicant: Fenwal, Inc.
- Decided: Mar 22, 2012 after 279 days
- Product code: LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K811078 (1981). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900105: Cobe Spectra Blood Component Separator Therapeutic, Cobe Laboratories, Inc. (1991) Summary page 2.
- K073339: Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector, Fenwal, Inc. (2008) Summary page 6.

## Cited in the summary but kept off the family tree
- K090065: Aerochamber Mini Ventilation Chamber, Trudell Medical Intl. (2009). The summary prints BK090065, a CBER number, which our reading took as K090065, FDA’s number for Aerochamber Mini Ventilation Chamber (Trudell Medical Intl.). 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 2.

## Most influential descendants
- K141019: Amicus Separator System/ Amicus Seperator System;Refurbished (2014), 1 descendant of its own
- K162462: AMICUS Separator System, AMICUS Separator System; Refurbished (2016), 0 descendants of its own

## Recalls of this device
- May 24, 2013 · Class II · Z-1523-2013: Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (whi

## Indications for use
The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). 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 procedure. For use with the AMICUS Separator System.

Source page: https://510kreport.com/device/K111702
Methodology: https://510kreport.com/methodology