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..

Clearance details

Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-01
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.