Cleared Traditional

K905646 - OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG...

K905646 is the FDA 510(k) clearance for OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG... by Norfolk Medical. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K905646 · Norfolk Medical · General Hospital
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Mar 1991
Decision
100d
Days
Class 2
Risk

K905646 is an FDA 510(k) clearance for the OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY. 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 March 27, 1991 after a review of 100 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

Submission Details

510(k) Number K905646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1990
Decision Date March 27, 1991
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
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 100
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K905646.
STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION
K905847 · Strato Medical Corp. · Apr 1991
STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED
K905851 · Strato Medical Corp. · Apr 1991
STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED
K905844 · Strato Medical Corp. · Apr 1991
PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM
K903220 · Pharmacia Deltec, Inc. · Oct 1990
Q-PORT SYSTEM KIT
K894650 · Quinton, Inc. · Mar 1990
LIFEPORT VASCULAR ACCESS PORT
K895689 · Strato Medical Corp. · Dec 1989