Cleared Traditional

K872329 - INFUSE-A-PORT ADDITIONAL SIZES

K872329 is an FDA 510(k) clearance for INFUSE-A-PORT ADDITIONAL SIZES, manufactured by Shiley Infusaid, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K872329 · Shiley Infusaid, Inc. · General Hospital
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Nov 1987
Decision
149d
Days
Class 2
Risk

K872329 is an FDA 510(k) clearance for the INFUSE-A-PORT ADDITIONAL SIZES. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Shiley Infusaid, Inc. (Norwood, US). The FDA issued a Cleared decision on November 13, 1987 after a review of 149 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.

View all Shiley Infusaid, Inc. devices

FDA 510(k) Submission Details - K872329

510(k) Number K872329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1987
Decision Date November 13, 1987
Days to Decision 149 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
20d slower than avg
Panel avg: 129d · This submission: 149d
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 K872329.
PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM
K875276 · Pharmacia Deltec, Inc. · Apr 1988
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
K875214 · Therex Corp. · Feb 1988
CHEMO-PORT
K874184 · Hdc Corp. · Dec 1987
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
K873735 · Medtronic Vascular · Nov 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213 · C.R. Bard, Inc. · Oct 1987
NORFOLK NORPORT (TM) -SP (SKIN PARALLEL)
K872838 · Norfolk Medical Products, Inc. · Aug 1987