Cleared Traditional

TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT (K913114) - FDA 510(k) Clearance

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

K913114 · Gerard Medical Enterprises, Inc. · General Hospital
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Jan 1992
Decision
178d
Days
Class 2
Risk

K913114 is an FDA 510(k) clearance for the TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Gerard Medical Enterprises, Inc. (Charlton, US). The FDA issued a Cleared decision on January 2, 1992 after a review of 178 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 K913114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 08, 1991
Decision Date January 02, 1992
Days to Decision 178 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
49d slower than avg
Panel avg: 129d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 223
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K913114.
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K920321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204
K912330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
NEEDLE*LESS DRUG VIAL ADAPTER
K894177 · Baxter Healthcare Corp · Sep 1989
DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN
K890082 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1989