Cleared Traditional

K863296 - INFUSE-A-PORT EXPLANT KIT

K863296 is an FDA 510(k) clearance for INFUSE-A-PORT EXPLANT KIT, manufactured by Intermedics/Infusaid, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K863296 · Intermedics/Infusaid, Inc. · General Hospital
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Sep 1986
Decision
17d
Days
Class 2
Risk

K863296 is an FDA 510(k) clearance for the INFUSE-A-PORT EXPLANT KIT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Intermedics/Infusaid, Inc. (Norwood, US). The FDA issued a Cleared decision on September 11, 1986 after a review of 17 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intermedics/Infusaid, Inc. devices

FDA 510(k) Submission Details - K863296

510(k) Number K863296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date September 11, 1986
Days to Decision 17 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
112d faster than avg
Panel avg: 129d · This submission: 17d
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 244
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K863296.
LIFE-PORT IMPLANTABLE VASCULAR ACCESS
K853827 · Strato Medical Corp. · Nov 1986
NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT
K863723 · Norfolk Medical Products, Inc. · Oct 1986
HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
K863305 · C.R. Bard, Inc. · Oct 1986
HDC CHEMO-PORT (VASCULAR)
K853332 · Hdc Corp. · Jul 1986
MEDTRONIC MODEL 8501 ACCESS PORT
K861498 · Medtronic Vascular · Jun 1986
IMPLANTOFIX
K851293 · Burron Medical Products, Inc. · Jan 1986