Cleared Traditional

K871209 - NORFOLK MEDICAL NORPORT

K871209 is the FDA 510(k) clearance for NORFOLK MEDICAL NORPORT by Norfolk Medical Products, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K871209 · Norfolk Medical Products, Inc. · General Hospital
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Jun 1987
Decision
91d
Days
Class 2
Risk

K871209 is an FDA 510(k) clearance for the NORFOLK MEDICAL NORPORT. 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 June 24, 1987 after a review of 91 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 Products, Inc. devices

Submission Details

510(k) Number K871209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1987
Decision Date June 24, 1987
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
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 106
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K871209.
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
K873735 · Medtronic Vascular · Nov 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213 · C.R. Bard, Inc. · Oct 1987
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817 · C.R. Bard, Inc. · Jul 1987
LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER
K870886 · Strato Medical Corp. · May 1987
HICKMAN TITANIUM SUBCUTANEOUS PORT
K870260 · C.R. Bard, Inc. · Apr 1987
PORT-A-CATH VASCULAR ACCESS SYSTEMS
K864446 · Pharmacia, Inc. · Mar 1987