Cleared Traditional

VITAL-PORT INFUSION PAL (K971140) - FDA 510(k) Clearance

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

K971140 · Med Institute, Inc. · General Hospital
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Nov 1997
Decision
234d
Days
Class 2
Risk

K971140 is an FDA 510(k) clearance for the VITAL-PORT INFUSION PAL. 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 November 17, 1997 after a review of 234 days - an extended review 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: 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 Med Institute, Inc. devices

Submission Details

510(k) Number K971140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date November 17, 1997
Days to Decision 234 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
105d slower than avg
Panel avg: 129d · This submission: 234d
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 43
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K971140.
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K982888 · Boston Scientific Corp · Oct 1998
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM
K964538 · Boston Scientific Corp · Mar 1997
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
K964066 · C.R. Bard, Inc. · Mar 1997
VASCULAR ACCESS PORT KIT
K955587 · Boston Scientific Corp · Mar 1996