FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
NovaLine Tubing Set for Hemodialysis (BL 124)
K Number: K252423
·
Decision May 15, 2026
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
76
Applicant Total
7
Review Days
287
Basic Information
- Device Name
- NovaLine Tubing Set for Hemodialysis (BL 124)
- K Number
- K252423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bain Medical Equipment (Guangzhou) Co., Ltd.
- Date Received
- August 1, 2025
- Decision Date
- May 15, 2026
- Product Code
- FJK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FJK), ordered by most recent decision date.
VITAL Tubing Sets for Hemodialysis
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Moda-flx Hemodialysis System Cartridge (102121-001 )
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CombiSet Hemodialysis Blood Tubing Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tablo Cartridge
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SANSIN Tubing Sets for Hemodialysis
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Bain Medical Equipment (Guangzhou) Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K240164 | NovaLine SP-C35 Transducer Protector (956007) | Jun 28, 2024 | Substantially Equivalent |
| K213015 | DORA Disposable A.V. Fistula Needle Sets | Apr 8, 2022 | Substantially Equivalent |
| K201866 | NovaLine Tubing Sets for Hemodialysis | Mar 10, 2021 | Substantially Equivalent |
| K203524 | Surgical Masks | Feb 25, 2021 | Substantially Equivalent |
| K163025 | DORA Disposable A.V. Fistula Needle Sets | Jul 20, 2017 | Substantially Equivalent |
| K161582 | DORA Tubing Sets for Hemodialysis | Jun 16, 2017 | Substantially Equivalent |