Cleared Traditional

LIFE-PORT IMPLANTABLE VASCULAR ACCESS (K853827) - FDA 510(k) Clearance

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

K853827 · Strato Medical Corp. · General Hospital
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Nov 1986
Decision
426d
Days
Class 2
Risk

K853827 is an FDA 510(k) clearance for the LIFE-PORT IMPLANTABLE VASCULAR ACCESS. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Strato Medical Corp. (Beverly, US). The FDA issued a Cleared decision on November 13, 1986 after a review of 426 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 Strato Medical Corp. devices

Submission Details

510(k) Number K853827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1985
Decision Date November 13, 1986
Days to Decision 426 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
297d slower than avg
Panel avg: 129d · This submission: 426d
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 42
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K853827.
HICKMAN TITANIUM SUBCUTANEOUS PORT
K870260 · C.R. Bard, Inc. · Apr 1987
MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT
K864349 · C.R. Bard, Inc. · Feb 1987
HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER
K863750 · C.R. Bard, Inc. · Dec 1986
HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
K863305 · C.R. Bard, Inc. · Oct 1986
MEDTRONIC MODEL 8501 ACCESS PORT
K861498 · Medtronic Vascular · Jun 1986
MEDTRONIC ACCESS PORT MODEL 8500
K853322 · Medtronic Vascular · Nov 1985