# K971687: Hemodialysis Venous Blood Tubing Set or Similar Trade Name

- Pathway: 510(k) (Traditional)
- Applicant: National Medical Care, Inc.
- Decided: Jul 29, 1997 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K041042: Split Septum Injection Sites (2004), 0 descendants of its own

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

Source page: https://510kreport.com/device/K971687
Methodology: https://510kreport.com/methodology