Cleared Traditional

DUAL PLASTIC VASCULAR ACCESS SYSTEM (K922147) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 47
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K922147.
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K894650 · Quinton, Inc. · Mar 1990
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K873213 · C.R. Bard, Inc. · Oct 1987