Cleared Traditional

K151076 - MicroTaper Needle Introducer Set

K151076 is an FDA 510(k) clearance for MicroTaper Needle Introducer Set, manufactured by Summit Access, LLC. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K151076 · Summit Access, LLC · Cardiovascular device
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May 2015
Decision
30d
Days
Class 2
Risk

K151076 is an FDA 510(k) clearance for the MicroTaper Needle Introducer Set. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Summit Access, LLC (Englewood, US). The FDA issued a Cleared decision on May 22, 2015 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Summit Access, LLC devices

FDA 510(k) Submission Details - K151076

510(k) Number K151076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2015
Decision Date May 22, 2015
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 59
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K151076.
van Andel Dilatation Catheter
K170616 · Cook Incorporated · Apr 2017
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
K162181 · Cardiacassist, Inc. · Jan 2017
VSI StraitSet micro-introducer kit
K161336 · Vascular Solutions, Inc. · Aug 2016
LEXICONTURE MECHANICAL DILATOR SHEATH SET
K140047 · Spectranetics Corp. · Apr 2014
NMI COAXIAL MICROINTRODUCER SET
K132713 · Navilyst Medical, Inc. · Sep 2013
PRELUDE SHEATH INTRODUCER
K130791 · Merit Medical Systems, Inc. · Jun 2013