# K251442: TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Tianyi Medical Appliance Co., Ltd.
- Decided: Oct 2, 2025 after 146 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: 6 generations back to K953823 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213992: CombiSet Hemodialysis Blood Tubing Set, Fresenius Medical Care Renal Therapies Group, LLC (2023) Summary page 5.

## Indications for use
TIANYI Extracorporeal Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. TIANYI Extracorporeal Blood Tubing Set is intended for acute and chronic hemodialysis therapy. TIANYI Extracorporeal Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T hemodialysis Machines.

Source page: https://510kreport.com/device/K251442
Methodology: https://510kreport.com/methodology