Cleared Traditional

K853322 - MEDTRONIC ACCESS PORT MODEL 8500

K853322 is an FDA 510(k) clearance for MEDTRONIC ACCESS PORT MODEL 8500, manufactured by Medtronic Vascular. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K853322 · Medtronic Vascular · General Hospital
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Nov 1985
Decision
90d
Days
Class 2
Risk

K853322 is an FDA 510(k) clearance for the MEDTRONIC ACCESS PORT MODEL 8500. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on November 6, 1985 after a review of 90 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K853322

510(k) Number K853322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1985
Decision Date November 06, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
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 287
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K853322.
IMPLANTOFIX
K851293 · Burron Medical Products, Inc. · Jan 1986
INFUSAID INFUSE-A-PORT (MODIFIED)
K853981 · Intermedics/Infusaid, Inc. · Dec 1985
PORT-GARD
K854019 · Cormed, Inc., Sub. C.R.Bard, Inc. · Nov 1985
STERILE CORMED MEDIPORT
K850967 · Cormed, Inc., Sub. C.R.Bard, Inc. · May 1985
PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV
K850888 · Creative Care Systems, Inc. · May 1985
INFUSE-A-PORT HEPARIN LOCK MAINT KIT
K840481 · Infusaid Corp. · Sep 1984
K853322 · MEDTRONIC ACCESS PORT MODEL 8500
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