Cleared Traditional

K141026 - LEADERFLEX

K141026 is an FDA 510(k) clearance for LEADERFLEX, manufactured by Vygon. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K141026 · Vygon · General Hospital
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Jul 2014
Decision
99d
Days
Class 2
Risk

K141026 is an FDA 510(k) clearance for the LEADERFLEX. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Vygon (Lansdale Montgomery, US). The FDA issued a Cleared decision on July 30, 2014 after a review of 99 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 Vygon devices

FDA 510(k) Submission Details - K141026

510(k) Number K141026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2014
Decision Date July 30, 2014
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
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 278
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K141026.
BD Angiocath IV Catheter, BD Insyte IV Catheter
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BioFlo Midline Catheter
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BD INTIMA II CLOSED IV CATHETER
K143610 · Becton Dickinson Infusion Therapy Systems, Inc. · Apr 2015
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
K140136 · Nipro Medical Corporation · Feb 2014
POWERGLIDE MIDLINE CATHETER
K133856 · C.R. Bard, Inc. · Jan 2014
SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
K132153 · Nipro Medical Corporation · Dec 2013