Cleared Traditional

K934520 - VITAL-PORT VASCULAR ACCESS SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934520 · Med Institute, Inc. · General Hospital
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Sep 1994
Decision
351d
Days
Class 2
Risk

K934520 is an FDA 510(k) clearance for the VITAL-PORT 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 September 6, 1994 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Med Institute, Inc. devices

Submission Details

510(k) Number K934520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1993
Decision Date September 06, 1994
Days to Decision 351 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 128d · This submission: 351d
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 286
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