Cleared Traditional

K162271 - Pro-Lock CT Safety Infusion Set (FDA 510(k) Clearance)

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

K162271 · Medcomp (Medical Components, Inc.) · General Hospital
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Apr 2017
Decision
257d
Days
Class 2
Risk

K162271 is an FDA 510(k) clearance for the Pro-Lock CT Safety Infusion Set. Classified as Non-coring (huber) Needle (product code PTI), Class II - Special Controls.

Submitted by Medcomp (Medical Components, Inc.) (Harleysville, US). The FDA issued a Cleared decision on April 26, 2017 after a review of 257 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 Medcomp (Medical Components, Inc.) devices

Submission Details

510(k) Number K162271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2016
Decision Date April 26, 2017
Days to Decision 257 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 128d · This submission: 257d
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 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 K162271.
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
PowerLoc™ Max Power Injectable Infusion Set
K241353 · Bard Access Systems, Inc. · Nov 2024
Promisemed Safety Huber Needle
K230715 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2023
Intera Refill Kit
K213823 · Intera Oncology, Inc. · Mar 2022