510(k) K251341
K251341 is an FDA 510(k) premarket notification submitted by Vital Healthcare Sdn. Bhd. for the device "VITAL Tubing Sets for Hemodialysis". The FDA issued a decision of Substantially Equivalent on January 16, 2026. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2026
- Date Received
- April 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type