Cleared Traditional

K904077 - VITAL-PORT DUAL LUMEN VASCULAR ACCESS S...

K904077 is an FDA 510(k) clearance for VITAL-PORT DUAL LUMEN VASCULAR ACCESS S..., manufactured by Med Institute, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K904077 · Med Institute, Inc. · General Hospital
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Oct 1990
Decision
42d
Days
Class 2
Risk

K904077 is an FDA 510(k) clearance for the VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Med Institute, Inc. (West Lafayette, US). The FDA issued a Cleared decision on October 17, 1990 after a review of 42 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Med Institute, Inc. devices

FDA 510(k) Submission Details - K904077

510(k) Number K904077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1990
Decision Date October 17, 1990
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 126
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K904077.
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