# K962081: Combilines Hemodialysis Blood Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: National Medical Care, Medical Products Div., Inc.
- Decided: Nov 1, 1996 after 157 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: 2 (0 Class I)
- 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. The FDA summary names no predicate by number.

## Most influential descendants
- K012242: Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets Hemodialysis Blood Tubing Sets (2001), 1 descendant of its own
- K041042: Split Septum Injection Sites (2004), 0 descendants of its own

## Recalls of this device
- Nov 19, 2010 · Not classified · Z-0843-2011: Hemodialysis Blood tubing Sets may develop kinking of the arterial line.
- Nov 19, 2010 · Not classified · Z-0844-2011: Hemodialysis Blood tubing Sets may develop kinking of the arterial line.

Source page: https://510kreport.com/device/K962081
Methodology: https://510kreport.com/methodology