# K202796: SANSIN Tubing Sets for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Sanxin Medtec Co., Ltd.
- Decided: Sep 6, 2021 after 348 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
Longest line of descent: 3 generations back to K010264 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161582: DORA Tubing Sets for Hemodialysis, Bain Medical Equipment (Guangzhou) Co., Ltd. (2017) Summary page 6.

## Indications for use
The SANSIN Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician/clinician in charge.

Source page: https://510kreport.com/device/K202796
Methodology: https://510kreport.com/methodology