Cleared Special

K112713 - NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS

K112713 is an FDA 510(k) clearance for NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS, manufactured by Norfolk Medical Products, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Special 510(k) pathway after a 38-day FDA review.

K112713 · Norfolk Medical Products, Inc. · General Hospital
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Oct 2011
Decision
38d
Days
Class 2
Risk

K112713 is an FDA 510(k) clearance for the NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on October 27, 2011 after a review of 38 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 Norfolk Medical Products, Inc. devices

FDA 510(k) Submission Details - K112713

510(k) Number K112713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2011
Decision Date October 27, 2011
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 233
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