# K201866: NovaLine Tubing Sets for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
- Decided: Mar 10, 2021 after 246 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.
2 later devices descend from it; 2 cite it directly.
0 of 6 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.

## Most influential descendants
- K252423: NovaLine Tubing Set for Hemodialysis (BL 124) (2026), 0 descendants of its own
- K251341: VITAL Tubing Sets for Hemodialysis (2026), 0 descendants of its own

## Indications for use
The NovaLine Tubing Sets for Hemodialysis - Models BL 11 and BL 12 - are sterile, single-use arterial and venous blood lines for exclusive use with the Baxter Healthcare AK98 Hemodialysis System. The blood lines serve 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/K201866
Methodology: https://510kreport.com/methodology