Cleared Traditional

K012256 - GELBISH VASCULAR DILATOR

K012256 is an FDA 510(k) clearance for GELBISH VASCULAR DILATOR, manufactured by Vascumetrix, LLC. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K012256 · Vascumetrix, LLC · Cardiovascular device
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Dec 2001
Decision
155d
Days
Class 2
Risk

K012256 is an FDA 510(k) clearance for the GELBISH VASCULAR DILATOR. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Vascumetrix, LLC (Meas, US). The FDA issued a Cleared decision on December 20, 2001 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vascumetrix, LLC devices

FDA 510(k) Submission Details - K012256

510(k) Number K012256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2001
Decision Date December 20, 2001
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRE Dilator, Vessel, For Percutaneous Catheterization

All 78
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K012256.
SUPER SHEATH INTRODUCER SHEATH
K052557 · Togo Medikit Co., Ltd. · Jan 2006
MERIT PRELUDE SHEATH INTRODUCER
K050962 · Merit Medical Systems, Inc. · May 2005
MERIT MAK (MINI ACCESS KIT)
K031691 · Merit Medical Systems, Inc. · Sep 2003
PERIPHERAL VASCULAR DILATOR
K974617 · Endovascular Instruments, Inc. · Dec 1998
URESIL DILATOR WITH RADIOPAQUE MARKER
K980282 · Uresil Corp. · Apr 1998
COAXIAL DILATOR SET
K974640 · Boston Scientific Corp · Mar 1998