Cleared Traditional

MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE (K912111) - FDA 510(k) Clearance

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

K912111 · Gerard Medical Enterprises, Inc. · General Hospital
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Oct 1991
Decision
148d
Days
Class 2
Risk

K912111 is an FDA 510(k) clearance for the MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Gerard Medical Enterprises, Inc. (Brimfield, US). The FDA issued a Cleared decision on October 8, 1991 after a review of 148 days - within the typical 510(k) review window.

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 K912111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date October 08, 1991
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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
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