Cleared Traditional

K111101 - NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET

K111101 is an FDA 510(k) clearance for NORPORT CT-PC, manufactured by Norfolk Medical. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K111101 · Norfolk Medical · General Hospital
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Aug 2011
Decision
127d
Days
Class 2
Risk

K111101 is an FDA 510(k) clearance for the NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Norfolk Medical (Skokie, US). The FDA issued a Cleared decision on August 25, 2011 after a review of 127 days - within the typical 510(k) review window.

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 Norfolk Medical devices

FDA 510(k) Submission Details - K111101

510(k) Number K111101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2011
Decision Date August 25, 2011
Days to Decision 127 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
2d faster than avg
Panel avg: 129d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 233
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K111101.
DIGNITY MINI PORT- ATTACHABLE
K110424 · Medcomp ( Medical Components) · Nov 2011
NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS
K112713 · Norfolk Medical Products, Inc. · Oct 2011
INVISIPORT
K110407 · Stealth Therapeutics, Incorporated · Oct 2011
NORFOLK MEDICAL NORPORT FAMILY OF PORTS
K102385 · Norfolk Medical Products, Inc. · Jan 2011
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
K101017 · AngioDynamics, Inc. · Jun 2010
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
K093414 · Smiths Medical Asd, Inc. · Mar 2010