Cleared Traditional

K870519 - SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY ...

K870519 is the FDA 510(k) clearance for SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY ... by Norfolk Medical Products, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K870519 · Norfolk Medical Products, Inc. · General Hospital
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Apr 1987
Decision
68d
Days
Class 2
Risk

K870519 is an FDA 510(k) clearance for the SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on April 15, 1987 after a review of 68 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 Norfolk Medical Products, Inc. devices

Submission Details

510(k) Number K870519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1987
Decision Date April 15, 1987
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 106
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K870519.
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817 · C.R. Bard, Inc. · Jul 1987
LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER
K870886 · Strato Medical Corp. · May 1987
HICKMAN TITANIUM SUBCUTANEOUS PORT
K870260 · C.R. Bard, Inc. · Apr 1987
PORT-A-CATH VASCULAR ACCESS SYSTEMS
K864446 · Pharmacia, Inc. · Mar 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