K252355 is an FDA 510(k) clearance for the K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5570. 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..
| 510(k) Number | K252355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |