Cleared Traditional

K840481 - INFUSE-A-PORT HEPARIN LOCK MAINT KIT

K840481 is an FDA 510(k) clearance for INFUSE-A-PORT HEPARIN LOCK MAINT KIT, manufactured by Infusaid Corp.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K840481 · Infusaid Corp. · General Hospital
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Sep 1984
Decision
225d
Days
Class 2
Risk

K840481 is an FDA 510(k) clearance for the INFUSE-A-PORT HEPARIN LOCK MAINT KIT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Infusaid Corp. (Mchenry, US). The FDA issued a Cleared decision on September 18, 1984 after a review of 225 days - an extended review 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: 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 Infusaid Corp. devices

FDA 510(k) Submission Details - K840481

510(k) Number K840481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1984
Decision Date September 18, 1984
Days to Decision 225 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
96d slower than avg
Panel avg: 129d · This submission: 225d
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 K840481.
MEDTRONIC MODEL 8501 ACCESS PORT
K861498 · Medtronic Vascular · Jun 1986
IMPLANTOFIX
K851293 · Burron Medical Products, Inc. · Jan 1986
MEDTRONIC ACCESS PORT MODEL 8500
K853322 · Medtronic Vascular · Nov 1985
VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD
K841679 · Norfolk Medical Products, Inc. · Jun 1984
VASCULAR ACCESS PORT CHANGES IN MATER
K840788 · Norfolk Medical Products, Inc. · Apr 1984
VASCULAR-ACCESS PORT - ENLARGEMENT
K841149 · Norfolk Medical Products, Inc. · Apr 1984