# K971313: NMC Hemodialysis Arterial Blood Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: National Medical Care, Inc.
- Decided: Oct 27, 1997 after 201 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
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 its predicate without a number.
- (no number) legally marketed bloodlines: named in the summary without a submission 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

## Indications for use
The Hemodialysis Arterial Blood Tubing Set is intended for use as the extra corporeal blood circuit during hemodialysis. It is intended for single use only. The Hemodialysis Arterial Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

Source page: https://510kreport.com/device/K971313
Methodology: https://510kreport.com/methodology