# K012242: Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets Hemodialysis Blood Tubing Sets

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care North America
- Decided: Aug 16, 2001 after 30 days
- Product code: FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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 K962081 (1996). 3 ancestors in all.
1 later device descends 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)
- K971313: NMC Hemodialysis Arterial Blood Tubing Set, National Medical Care, Inc. (1997) Summary page 2.
- K962081: Combilines Hemodialysis Blood Tubing Set, National Medical Care, Medical Products Div., Inc. (1996) Summary page 2.
- K000451: Fresenius Combillines Single Needle Blood Tubing Set, Catalog #03-2290, Fresenius Medical Care North America (2000) Summary page 2.

## Most influential descendants
- K041042: Split Septum Injection Sites (2004), 0 descendants of its own

## Indications for use
The Fresenius Single use Arterial Bloodline Sets are intended for use as the extracorporeal blood circuit during hemodialysis. They are intended for single use only and are indicated for use with both conventional and high flux negative pressure hemodialyzer equipment.

Source page: https://510kreport.com/device/K012242
Methodology: https://510kreport.com/methodology