Cleared Traditional

K241353 - PowerLoc™ Max Power Injectable Infusion Set

Also marketed or referenced as:
SafeStep™ Huber Needle Set

K241353 is an FDA 510(k) clearance for PowerLoc Max Power Injectable Infusion Set, manufactured by Bard Access Systems, Inc.. The device is a Class 2 General Hospital device with product code PTI cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K241353 · Bard Access Systems, Inc. · General Hospital
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Nov 2024
Decision
198d
Days
Class 2
Risk

K241353 is an FDA 510(k) clearance for the PowerLoc™ Max Power Injectable Infusion Set. Classified as Non-coring (huber) Needle (product code PTI), Class II - Special Controls.

Submitted by Bard Access Systems, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on November 27, 2024 after a review of 198 days - an extended review cycle.

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 Bard Access Systems, Inc. devices

FDA 510(k) Submission Details - K241353

510(k) Number K241353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2024
Decision Date November 27, 2024
Days to Decision 198 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
69d slower than avg
Panel avg: 129d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PTI Device Classification - Class 2, Special Controls

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 Peers - PTI Non-coring (huber) Needle

All 12
Devices cleared under the same product code (PTI) and FDA review panel - the closest regulatory comparables to K241353.
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
K252355 · Sb-Kawasumi Laboratories, Inc. · Nov 2025
Promisemed Safety Huber Needles
K251138 · Promisemed Hangzhou Meditech Co., Ltd. · May 2025
Promisemed Safety Huber Needles
K243332 · Promisemed Hangzhou Meditech Co., Ltd. · Mar 2025
Promisemed Safety Huber Needle
K230715 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2023
Intera Refill Kit
K213823 · Intera Oncology, Inc. · Mar 2022
Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
K211121 · Intera Oncology, Inc. · Oct 2021