Cleared Traditional

K213855 - Arrow Pressure Injectable Midline Catheter (FDA 510(k) Clearance)

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

K213855 · Arrow International, LLC Subsidiary of Teleflex Incorporated · General Hospital
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Sep 2022
Decision
266d
Days
Class 2
Risk

K213855 is an FDA 510(k) clearance for the Arrow Pressure Injectable Midline Catheter. Classified as Midline Catheter (product code PND), Class II - Special Controls.

Submitted by Arrow International, LLC Subsidiary of Teleflex Incorporated (Morrisville, US). The FDA issued a Cleared decision on September 2, 2022 after a review of 266 days - an extended review cycle.

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, LLC Subsidiary of Teleflex Incorporated devices

Submission Details

510(k) Number K213855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2021
Decision Date September 02, 2022
Days to Decision 266 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
138d slower than avg
Panel avg: 128d · This submission: 266d
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.