Cleared Traditional

K150611 - MedSource ClearSafe Safety IV Catheter

K150611 is an FDA 510(k) clearance for MedSource ClearSafe Safety IV Catheter, manufactured by Medsource International. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K150611 · Medsource International · General Hospital
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Jul 2015
Decision
127d
Days
Class 2
Risk

K150611 is an FDA 510(k) clearance for the MedSource ClearSafe Safety IV Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Medsource International (Chaska, US). The FDA issued a Cleared decision on July 15, 2015 after a review of 127 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 International devices

FDA 510(k) Submission Details - K150611

510(k) Number K150611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2015
Decision Date July 15, 2015
Days to Decision 127 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
2d faster than avg
Panel avg: 129d · This submission: 127d
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 321
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K150611.
PowerGlide Pro Midline Catheter
K153280 · C.R. Bard, Inc. · Jun 2016
AccuCath Intravascular Catheter
K153298 · C.R. Bard, Inc. · Dec 2015
BD Angiocath IV Catheter, BD Insyte IV Catheter
K151698 · Becton Dickinson Infusion Therapy Systems, Inc. · Jul 2015
BioFlo Midline Catheter
K150407 · Navilyst Medical, Inc. · May 2015
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