Cleared Traditional

LIFE-LINE(TM) VASCULAR ACCESS SYSTEM (K895030) - FDA 510(k) Clearance

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

K895030 · Medical Engineering and Development Institute · General Hospital
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Apr 1990
Decision
252d
Days
Class 2
Risk

K895030 is an FDA 510(k) clearance for the LIFE-LINE(TM) VASCULAR ACCESS SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Medical Engineering and Development Institute (West Lafayette, US). The FDA issued a Cleared decision on April 17, 1990 after a review of 252 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 Medical Engineering and Development Institute devices

Submission Details

510(k) Number K895030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 08, 1989
Decision Date April 17, 1990
Days to Decision 252 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
123d slower than avg
Panel avg: 129d · This submission: 252d
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 47
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K895030.
CELSITE VENOUS ACCESS SYSTEM OTW
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K952748 · United States Surgical, A Division of Tyco Healthc · Aug 1995
CELSITE VENOUS SYSTEM
K952548 · B.Braun Medical, Inc. · Jul 1995
Q-PORT SYSTEM KIT
K894650 · Quinton, Inc. · Mar 1990
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
K873735 · Medtronic Vascular · Nov 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213 · C.R. Bard, Inc. · Oct 1987