Cleared Traditional

K922147 - DUAL PLASTIC VASCULAR ACCESS SYSTEM

K922147 is an FDA 510(k) clearance for DUAL PLASTIC VASCULAR ACCESS SYSTEM, manufactured by Gerard Medical Enterprises, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K922147 · Gerard Medical Enterprises, Inc. · General Hospital
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Dec 1992
Decision
211d
Days
Class 2
Risk

K922147 is an FDA 510(k) clearance for the DUAL PLASTIC VASCULAR ACCESS SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Gerard Medical Enterprises, Inc. (Charlton, US). The FDA issued a Cleared decision on December 4, 1992 after a review of 211 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 Gerard Medical Enterprises, Inc. devices

FDA 510(k) Submission Details - K922147

510(k) Number K922147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1992
Decision Date December 04, 1992
Days to Decision 211 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 129d · This submission: 211d
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 236
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K922147.
PHARMACIA DELTEC WINGED INFUSION SET
K923019 · Pharmacia Deltec, Inc. · Apr 1993
VITAL-PORT VASCULAR ACCESS SYSTEM W/ INJECTROL
K922896 · Med Institute, Inc. · Mar 1993
A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODI
K926011 · Therex Corp. · Mar 1993
IPI IMPORT
K922419 · Pudenz-Schulte Medical Research Corp. · Nov 1992
A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT
K921379 · Therex Corp. · Nov 1992
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT
K922434 · Therex Corp. · Nov 1992