Cleared Traditional

K913114 - TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT

K913114 is an FDA 510(k) clearance for TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL ..., manufactured by Gerard Medical Enterprises, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 178-day FDA review.

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

FDA 510(k) Submission Details - K913114

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.

FMF Device Classification - Class 2, Special Controls

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 481
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K913114.
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DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH
K913235 · Davol, Inc. · Oct 1991
B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204
K912330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR
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