Cleared Traditional

MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter (K161779) - FDA 510(k) Clearance

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

K161779 · Medsource International, LLC · General Hospital
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Nov 2016
Decision
127d
Days
Class 2
Risk

K161779 is an FDA 510(k) clearance for the MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV C.... Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Medsource International, LLC (Chaska, US). The FDA issued a Cleared decision on November 3, 2016 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, LLC devices

Submission Details

510(k) Number K161779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2016
Decision Date November 03, 2016
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.

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 137
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K161779.
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
K170336 · Becton, Dickinson and Company · Mar 2017
BD Nexiva Diffusics Closed IV Catheter System
K170283 · Becton, Dickinson and Company · Feb 2017
AccuCath Intravascular Catheter
K162894 · C.R. Bard, Inc. · Nov 2016
PowerGlide Pro Midline Catheter
K162377 · C.R. Bard, Inc. · Sep 2016
PowerGlide Pro Midline Catheter
K153280 · C.R. Bard, Inc. · Jun 2016
AccuCath Intravascular Catheter
K153298 · C.R. Bard, Inc. · Dec 2015