Cleared Special

K050176 - VORTEX EZ VASCULAR ACCESS PORT

K050176 is an FDA 510(k) clearance for VORTEX EZ VASCULAR ACCESS PORT, manufactured by Rita Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Special 510(k) pathway after a 30-day FDA review.

K050176 · Rita Medical Systems, Inc. · General Hospital
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Feb 2005
Decision
30d
Days
Class 2
Risk

K050176 is an FDA 510(k) clearance for the VORTEX EZ VASCULAR ACCESS PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Rita Medical Systems, Inc. (Manchester, US). The FDA issued a Cleared decision on February 25, 2005 after a review of 30 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 Rita Medical Systems, Inc. devices

FDA 510(k) Submission Details - K050176

510(k) Number K050176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2005
Decision Date February 25, 2005
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

LJT Device Classification - Class 2, Special Controls

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 226
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K050176.
POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE
K060812 · C.R. Bard, Inc. · Jul 2006
PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER
K060036 · Smiths Medical MD, Inc. · May 2006
BARDPORT TITANIUM PORTS
K050310 · Bard Access Systems, Inc. · Apr 2005
PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM
K033686 · Smiths Medical MD, Inc. · Jan 2004
MODIFICATION TO X-PORT DUO PORT
K034065 · C.R. Bard, Inc. · Jan 2004
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
K033473 · Horizon Medical Products, Inc. · Nov 2003