Cleared Traditional

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K161313) - FDA 510(k) Clearance

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

K161313 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · General Hospital
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Aug 2016
Decision
106d
Days
Class 2
Risk

K161313 is an FDA 510(k) clearance for the ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and.... Classified as Midline Catheter (product code PND), Class II - Special Controls.

Submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, US). The FDA issued a Cleared decision on August 24, 2016 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) devices

Submission Details

510(k) Number K161313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2016
Decision Date August 24, 2016
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PND Midline Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.
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 - PND Midline Catheter

All 12
Devices cleared under the same product code (PND) and FDA review panel - the closest regulatory comparables to K161313.
Midline Catheter
K252402 · Terumo Medical Products Hangzhou Co., Ltd. · Dec 2025
Arrow Pressure Injectable Midline Catheter
K213855 · Arrow International, LLC Subsidiary of Teleflex Incorporated · Sep 2022
Provena(TM) Midline Catheter
K213203 · C.R. Bard, Inc. · May 2022
Stiletto Extended Dwell Catheter
K210047 · Piper Access, LLC · Aug 2021
primeMidline Catheters
K192802 · Pfm Medical, Inc. · Oct 2019
Vygon Midline 3 Fr SL Catheter
K181208 · Vygon USA · Nov 2018