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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRE Dilator, Vessel, For Percutaneous Catheterization

All 89
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K151076.
Sheath Introducer
K150932 · Bioteque Corp. · Jul 2016
TightRail Sub-C Rotating Dilator Sheath
K161333 · Spectranetics, Inc. · Jul 2016
MicroTract Access System
K151877 · Arstasis, Inc. · Aug 2015
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
K150360 · Spectranetics, Inc. · Mar 2015
SUPER SHEATH
K141070 · Togo Medikit Co., Ltd. · Jan 2015
Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath
K142301 · Cook Vascular, Inc. · Nov 2014