Cleared Special

K022983 - BARDPORT X-PORT ISP PORT

K022983 is an FDA 510(k) clearance for BARDPORT X-PORT ISP PORT, manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Special 510(k) pathway after a 16-day FDA review.

K022983 · C.R. Bard, Inc. · General Hospital
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Sep 2002
Decision
16d
Days
Class 2
Risk

K022983 is an FDA 510(k) clearance for the BARDPORT X-PORT ISP PORT. 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 September 25, 2002 after a review of 16 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K022983

510(k) Number K022983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date September 25, 2002
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
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 235
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K022983.
X-PROT DUO PORT
K032044 · C.R. Bard, Inc. · Jul 2003
OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05
K021580 · LeMaitre Vascular, Inc. · Feb 2003
VAXCEL WITH PASV PORT
K030083 · Boston Scientific Corp · Jan 2003
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
K010767 · Horizon Medical Products, Inc. · Apr 2001
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
K010426 · Sims Deltec, Inc. · Mar 2001
VORTEX ACCESS SYSTEM
K010189 · Horizon Medical Products, Inc. · Feb 2001