# K954676: Nipro Arterial & Venous Blood Tubing Set for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Nissho Corp.
- Decided: Mar 4, 1997 after 511 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Kawasumi Blood Tubing Line: named in the summary without a submission number
- (no number) gambro® Blood line set for hemodialysis: named in the summary without a submission number

## Indications for use
The blood tubing sets are used to transport blood or fluids to a patient's vascular access device from a hemodialyzer. The reverse is also true in that the tubing set is used as to transport blood or fluids from a patient's vascular access device to a hemodialyzer.

Source page: https://510kreport.com/device/K954676
Methodology: https://510kreport.com/methodology