# K041042: Split Septum Injection Sites

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care North America
- Decided: Jul 16, 2004 after 85 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962081 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962081: Combilines Hemodialysis Blood Tubing Set, National Medical Care, Medical Products Div., Inc. (1996) Summary page 1.
- K001107: Fresenius Combilines Low Volume Blood Tubing Set,  Models 03-2291 (Post Pump) and 03-2292 (Pre-Pump), Fresenius Medical Care North America (2000)
- K000451: Fresenius Combillines Single Needle Blood Tubing Set, Catalog #03-2290, Fresenius Medical Care North America (2000) Summary page 1.
- K971313: NMC Hemodialysis Arterial Blood Tubing Set, National Medical Care, Inc. (1997) Summary page 1.
- K971687: Hemodialysis Venous Blood Tubing Set or Similar Trade Name, National Medical Care, Inc. (1997) Summary page 1.
- K012242: Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets Hemodialysis Blood Tubing Sets, Fresenius Medical Care North America (2001) Summary page 1.

## Indications for use
The Fresenius CombSets are intended for use as the extracorporeal blood circuit during Hemodialysis. They are intended for single use only. The CombiSets are indicated for use with conventional and high flux negative pressure hemodialyzer equipment. The Fresenius Venous Bloodline is intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. The Fresenius Arterial Bloodline is intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Fresenius Arterial Bloodline is intended to for use with conventional and high flux negative pressure hemodialyzer equipment.

Source page: https://510kreport.com/device/K041042
Methodology: https://510kreport.com/methodology