Cleared Traditional

K252355 - K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252355 · Sb-Kawasumi Laboratories, Inc. · General Hospital
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Nov 2025
Decision
120d
Days
Class 2
Risk

K252355 is an FDA 510(k) clearance for the K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing. Classified as Non-coring (huber) Needle (product code PTI), Class II - Special Controls.

Submitted by Sb-Kawasumi Laboratories, Inc. (Kanagawa, JP). The FDA issued a Cleared decision on November 26, 2025 after a review of 120 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sb-Kawasumi Laboratories, Inc. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 128d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PTI Non-coring (huber) Needle
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Regulatory Compliance Associates, Inc. (Rca)
Valerie Followell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PTI Non-coring (huber) Needle

All 12
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Intera Refill Kit
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K211121 · Intera Oncology, Inc. · Oct 2021