FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇾 Malaysia
VITAL Tubing Sets for Hemodialysis
K Number: K251341
·
Decision Jan 16, 2026
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
76
Applicant Total
1
Review Days
261
Basic Information
- Device Name
- VITAL Tubing Sets for Hemodialysis
- K Number
- K251341
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vital Healthcare Sdn. Bhd.
- Date Received
- April 30, 2025
- Decision Date
- January 16, 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.
NovaLine Tubing Set for Hemodialysis (BL 124)
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