Cleared Traditional

K150514 - Power-Injectable Implantable Ports with...

K150514 is the FDA 510(k) clearance for Power-Injectable Implantable Ports with... by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K150514 · C.R. Bard, Inc. · General Hospital
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Nov 2015
Decision
266d
Days
Class 2
Risk

K150514 is an FDA 510(k) clearance for the Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 20, 2015 after a review of 266 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K150514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2015
Decision Date November 20, 2015
Days to Decision 266 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
137d slower than avg
Panel avg: 129d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 61
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K150514.
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
K190559 · AngioDynamics, Inc. · May 2020
Bard Power-Injectable Implantable Ports (PowerPorts®)
K181446 · C.R. Bard, Inc. · Jul 2019
BardPort®, SlimPort®, and X-Port® Implanted Ports
K153359 · C.R. Bard, Inc. · May 2016
Vital-Port Vascular Access System Power Injectable Port
K150733 · Cook Incorporated · May 2015
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
K140169 · Cook Incorporated · May 2014
POWERPORT IMPLANTABLE PORT
K133335 · C.R. Bard, Inc. · Feb 2014