# K961706: P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius USA, Inc.
- Decided: Jul 31, 1996 after 90 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050910: Roei Working Element and Roel Cutting Loops (2005), 1 descendant of its own
- K060734: Fresenius Com.Tec Automated Cell Separator, Model 9008031; Fresenius C5L, S5L, C5L-T Platelet Sets (5-Day Storage) (2006), 0 descendants of its own
- K053322: Modification to: Roei Working Element and Roei Cutting Loops (2006), 0 descendants of its own

## Recalls of this device
- Apr 19, 2011 · Not classified · Z-2199-2011: Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0

Source page: https://510kreport.com/device/K961706
Methodology: https://510kreport.com/methodology