# K014140: Renax Hemodialysis Blood Tubing Set; Sunder Hemodialysis Blood Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Sunder Biomedical Tech. Co., Ltd.
- Decided: Nov 18, 2002 after 336 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The RENAX (SUNDER) HEMODIKYSIS BLOOD TUBING SET (model: SD-KOl, SD-GOl) is intended to serve as a conduit through which blood is taken from the patient, delivered to the hemodialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering fiom renal disease only.

Source page: https://510kreport.com/device/K014140
Methodology: https://510kreport.com/methodology