Cleared Traditional

Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620) (K242281) - FDA 510(k) Clearance

Also marketed or referenced as:
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622) Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820) Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)

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

K242281 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
140d
Days
Class 2
Risk

K242281 is an FDA 510(k) clearance for the Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620). Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Arrow International, LLC (A subsidiary of Teleflex, Inc.) (Morrisville, US). The FDA issued a Cleared decision on December 20, 2024 after a review of 140 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, LLC (A subsidiary of Teleflex, Inc.) devices

Submission Details

510(k) Number K242281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2024
Decision Date December 20, 2024
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 132
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K242281.
OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
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K244059 · Access Vascular, Inc. · Mar 2025
Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
K243599 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Mar 2025
SV Spectrum MRC Central Venous Catheter
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K241845 · B.Braun Medical, Inc. · Jul 2024