Cleared Traditional

K954258 - TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)

K954258 is an FDA 510(k) clearance for TRIMPORT IMPLANTABLE ACCESS SYSTEM (MOD..., 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 262-day FDA review.

K954258 · Gerard Medical Enterprises, Inc. · General Hospital
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May 1996
Decision
262d
Days
Class 2
Risk

K954258 is an FDA 510(k) clearance for the TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION). 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 May 24, 1996 after a review of 262 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 - K954258

510(k) Number K954258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date May 24, 1996
Days to Decision 262 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 129d · This submission: 262d
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 235
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K954258.
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