Cleared Traditional

K932411 - VITAL-PORT VASC ACCESS SYS W/DUAL LUM I...

K932411 is an FDA 510(k) clearance for VITAL-PORT VASC ACCESS SYS W/DUAL LUM I..., 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 489-day FDA review.

K932411 · Med Institute, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 1994
Decision
489d
Days
Class 2
Risk

K932411 is an FDA 510(k) clearance for the VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA. 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 19, 1994 after a review of 489 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Med Institute, Inc. devices

FDA 510(k) Submission Details - K932411

510(k) Number K932411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1993
Decision Date September 19, 1994
Days to Decision 489 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
360d slower than avg
Panel avg: 129d · This submission: 489d
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
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