# K895435: Fresenius as 104 Cell Separator

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius USA, Inc.
- Decided: Nov 2, 1990 after 421 days
- Product code: LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- 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
- K050273: Fresenius Art Hemoadsorption System (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K895435
Methodology: https://510kreport.com/methodology