Cleared Traditional

HDC CHEMO-PORT (VASCULAR) (K853332) - FDA 510(k) Clearance

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

K853332 · Hdc Corp. · General Hospital
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Jul 1986
Decision
343d
Days
Class 2
Risk

K853332 is an FDA 510(k) clearance for the HDC CHEMO-PORT (VASCULAR). Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Hdc Corp. (Mountain View, US). The FDA issued a Cleared decision on July 17, 1986 after a review of 343 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Hdc Corp. devices

Submission Details

510(k) Number K853332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1985
Decision Date July 17, 1986
Days to Decision 343 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
214d slower than avg
Panel avg: 129d · This submission: 343d
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 50
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K853332.
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
PORT-A-CATH
K832917 · Pharmacia, Inc. · Dec 1983