Cleared Traditional

K901419 - DUAL PORT

K901419 is an FDA 510(k) clearance for DUAL PORT, 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 163-day FDA review.

K901419 · Infusaid Corp. · General Hospital
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Sep 1990
Decision
163d
Days
Class 2
Risk

K901419 is an FDA 510(k) clearance for the DUAL PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Infusaid Corp. (Norwood, US). The FDA issued a Cleared decision on September 5, 1990 after a review of 163 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 - K901419

510(k) Number K901419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date September 05, 1990
Days to Decision 163 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
34d slower than avg
Panel avg: 129d · This submission: 163d
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 K901419.
VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K904077 · Med Institute, Inc. · Oct 1990
A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX.
K903691 · Therex Corp. · Oct 1990
PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM
K903220 · Pharmacia Deltec, Inc. · Oct 1990
Q-PORT SYSTEM KIT
K894650 · Quinton, Inc. · Mar 1990
LIFEPORT VASCULAR ACCESS PORT
K895689 · Strato Medical Corp. · Dec 1989
A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT
K896093 · Therex Corp. · Dec 1989