DeviceClearance

NovaLine Tubing Set for Hemodialysis (BL 124)— 510(k) K252423

Substantially Equivalent

Bain Medical Equipment (Guangzhou) Co., Ltd.

FDA 510(k) clearance K252423 for NovaLine Tubing Set for Hemodialysis (BL 124), Substantially Equivalent on 2026-05-15. Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.. Device class: 2.

Summary

Bain Medical Equipment (Guangzhou)'s NovaLine Tubing Set for Hemodialysis (BL 124) is filed under FJK, blood tubing sets with and without anti-regurgitation valve.

Class II, 21 CFR 876.5820. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Bain filed from Guangzhou, China. Review took 287 calendar days (August 1, 2025 to May 15, 2026).

Clearance details

Applicant
Bain Medical Equipment (Guangzhou) Co., Ltd.
Product code
Product code FJK
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guangzhou, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FJK

product code FJK
Death
52
Malfunction
3,430
Total
3,482

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.