Cleared Traditional

K260539 - MedSource QuickSafe™ Safety IV Catheter

Also marketed or referenced as:
MedSource PurSafe™ Safety IV Catheter

K260539 is an FDA 510(k) clearance for MedSource QuickSafe Safety IV Catheter, manufactured by MedSource Labs, LLC. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K260539 · MedSource Labs, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
142d
Days
Class 2
Risk

K260539 is an FDA 510(k) clearance for the MedSource QuickSafe™ Safety IV Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by MedSource Labs, LLC (Chanhassen, US). The FDA issued a Cleared decision on July 9, 2026 after a review of 142 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 MedSource Labs, LLC devices

FDA 510(k) Submission Details - K260539

510(k) Number K260539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2026
Decision Date July 09, 2026
Days to Decision 142 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
13d slower than avg
Panel avg: 129d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

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 399
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K260539.
Unimpregnated Central Venous Catheter
K260165 · Spectrum Vascular · Aug 2026
ClearSafe Closed System
K261041 · MedSource Labs, LLC · Jul 2026
Introcan Safety® Deep Access XL IV Catheter
K253235 · B.Braun Medical, Inc. · May 2026
BD Insyte™ IV Catheter
K252137 · Becton Dickinson Infusion Therapy Systems, Inc. · Apr 2026
Polywin Safety (14G x 51mm
K252513 · Poly Medicure Limited · Apr 2026
SURFLO Hybria Closed System Safety IV Catheter
K252398 · Terumo Medical Products Hangzhou Co., Ltd. · Dec 2025