# K252423: NovaLine Tubing Set for Hemodialysis (BL 124)

- Pathway: 510(k) (Traditional)
- Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
- Decided: May 15, 2026 after 287 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: 4 generations back to K010264 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201866: NovaLine Tubing Sets for Hemodialysis, Bain Medical Equipment (Guangzhou) Co., Ltd. (2021) Summary page 6.

## Indications for use
The NovaLine Tubing Set for Hemodialysis - BL 124 - is sterile, single-use arterial and venous blood line for exclusive use with the Vantive AK 98 delivery System. The bloodline serves as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit.

Source page: https://510kreport.com/device/K252423
Methodology: https://510kreport.com/methodology