Cleared Special

K150733 - Vital-Port Vascular Access System Power...

K150733 is the FDA 510(k) clearance for Vital-Port Vascular Access System Power... by Cook Incorporated. It is a Class 2 General Hospital device (product code LJT) cleared through the Special 510(k) pathway after a 62-day FDA review.

K150733 · Cook Incorporated · General Hospital
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May 2015
Decision
62d
Days
Class 2
Risk

K150733 is an FDA 510(k) clearance for the Vital-Port Vascular Access System Power Injectable Port. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 21, 2015 after a review of 62 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cook Incorporated devices

Submission Details

510(k) Number K150733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2015
Decision Date May 21, 2015
Days to Decision 62 days
Submission Type Special
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
67d faster than avg
Panel avg: 129d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

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 K150733.
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
Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
K150514 · C.R. Bard, Inc. · Nov 2015
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
K140169 · Cook Incorporated · May 2014
POWERPORT IMPLANTABLE PORT
K133335 · C.R. Bard, Inc. · Feb 2014
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
K122899 · C.R. Bard, Inc. · Nov 2012