Cleared Traditional

K122899 - POWERPORT CLEARVUE SLIM IMPLANTABLE PORT

K122899 is the FDA 510(k) clearance for POWERPORT CLEARVUE SLIM IMPLANTABLE PORT 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 55-day FDA review.

K122899 · C.R. Bard, Inc. · General Hospital
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Nov 2012
Decision
55d
Days
Class 2
Risk

K122899 is an FDA 510(k) clearance for the POWERPORT CLEARVUE SLIM IMPLANTABLE PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on November 15, 2012 after a review of 55 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K122899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2012
Decision Date November 15, 2012
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 K122899.
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POWERPORT IMPLANTABLE PORT
K133335 · C.R. Bard, Inc. · Feb 2014
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
K101017 · AngioDynamics, Inc. · Jun 2010
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
K090512 · C.R. Bard, Inc. · Mar 2009
SMARTPORT CT VORTEX
K081472 · AngioDynamics, Inc. · Sep 2008