Cleared Traditional

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing

K252355 · Sb-Kawasumi Laboratories, Inc. · General Hospital

Nov 2025

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K252355 is an FDA 510(k) clearance for the K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing, a Non-coring (huber) Needle (Class II — Special Controls, product code PTI), submitted by Sb-Kawasumi Laboratories, Inc. (Kanagawa, JP). The FDA issued a Cleared decision on November 26, 2025, 120 days after receiving the submission on July 29, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K252355 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2025
Decision Date	November 26, 2025
Days to Decision	120 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PTI — Non-coring (huber) Needle
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5570
Definition	The Non-coring Needle (huber) Is Utilized To Gain Access Into A Subcutaneous Implanted Intravascular Infusion Port But Can Also Be Used To Access Other Non-vascular Implanted Devices With Similar Septums.