Cleared Traditional

K894650 - Q-PORT SYSTEM KIT

K894650 is the FDA 510(k) clearance for Q-PORT SYSTEM KIT by Quinton, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K894650 · Quinton, Inc. · General Hospital
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Mar 1990
Decision
231d
Days
Class 2
Risk

K894650 is an FDA 510(k) clearance for the Q-PORT SYSTEM KIT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on March 12, 1990 after a review of 231 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 Quinton, Inc. devices

Submission Details

510(k) Number K894650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date March 12, 1990
Days to Decision 231 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 129d · This submission: 231d
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 124
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K894650.
STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED
K905851 · Strato Medical Corp. · Apr 1991
STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED
K905844 · Strato Medical Corp. · Apr 1991
PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM
K903220 · Pharmacia Deltec, Inc. · Oct 1990
LIFEPORT VASCULAR ACCESS PORT
K895689 · Strato Medical Corp. · Dec 1989
LIFEPORT POLYURETHANE CATHETER
K895871 · Strato Medical Corp. · Nov 1989
LIFEPORT II, MODEL LPS-1100
K881075 · Strato Medical Corp. · Jun 1988