K252423
- 510(k) number
- K252423
- Device name
- NovaLine Tubing Set for Hemodialysis (BL 124)
- Applicant
- Bain Medical Equipment (Guangzhou) Co., Ltd. CN
- Product code
- FJK — Set, Tubing, Blood, With And Without Anti-Regurgitat
- Decision date
- 2026-05-15
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252423.pdf
Official FDA record: K252423
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.