Clearance Summary
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing received FDA 510(k) clearance under submission number K252355, sponsored by Sb-Kawasumi Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-11-26.
- Submission: K252355
- Applicant / Sponsor: Sb-Kawasumi Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2025-11-26
Classification & Regulation
This clearance is catalogued under FDA product code PTI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.