Cleared Traditional

K905646 - OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY

K905646 is an FDA 510(k) clearance for OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG..., 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 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

FDA 510(k) Submission Details - K905646

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.

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 234
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
VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM
K910005 · Med Institute, Inc. · Mar 1991
VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K904077 · Med Institute, Inc. · Oct 1990
A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX.
K903691 · Therex Corp. · Oct 1990