Clearance Summary
VITAL Tubing Sets for Hemodialysis received FDA 510(k) clearance under submission number K251341, sponsored by Vital Healthcare Sdn. Bhd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-01-16.
- Submission: K251341
- Applicant / Sponsor: Vital Healthcare Sdn. Bhd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2026-01-16
Classification & Regulation
This clearance is catalogued under FDA product code FJK and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.