# K060734: Fresenius Com.Tec Automated Cell Separator, Model 9008031; Fresenius C5L, S5L, C5L-T Platelet Sets (5-Day Storage)

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Sep 5, 2006 after 169 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
Longest line of descent: 1 generation back to K895435 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895435: Fresenius as 104 Cell Separator, Fresenius USA, Inc. (1990) Summary page 1.
- K961706: P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator, Fresenius USA, Inc. (1996) Summary page 1.

## Indications for use
The COMTEC Blood Cell Separator is a blood component separator which utilizes centrifugal force as the basis of operation. The fields of application are as follows: -plasma exchange - plasma treatment

Source page: https://510kreport.com/device/K060734
Methodology: https://510kreport.com/methodology