Cleared Traditional

K870187 - NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT

K870187 is an FDA 510(k) clearance for NORFOLK NORPORT, manufactured by Norfolk Medical Products, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K870187 · Norfolk Medical Products, Inc. · General Hospital
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May 1987
Decision
111d
Days
Class 2
Risk

K870187 is an FDA 510(k) clearance for the NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT. 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 May 7, 1987 after a review of 111 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

FDA 510(k) Submission Details - K870187

510(k) Number K870187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1987
Decision Date May 07, 1987
Days to Decision 111 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
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 K870187.
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817 · C.R. Bard, Inc. · Jul 1987
NORFOLK MEDICAL NORPORT
K871209 · Norfolk Medical Products, Inc. · Jun 1987
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
K871192 · Norfolk Medical Products, Inc. · Jun 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
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
K870519 · Norfolk Medical Products, Inc. · Apr 1987