Cleared Traditional

K110051 - RADIALSOURCE TRANSRADIAL ACCESS INTRODU...

K110051 is an FDA 510(k) clearance for RADIALSOURCE TRANSRADIAL ACCESS INTRODU..., manufactured by Great Batch Medical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K110051 · Great Batch Medical · Cardiovascular device
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Feb 2012
Decision
391d
Days
Class 2
Risk

K110051 is an FDA 510(k) clearance for the RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Great Batch Medical (Plymouth, US). The FDA issued a Cleared decision on February 2, 2012 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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. Elevated predicate reliance profile. 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 Great Batch Medical devices

FDA 510(k) Submission Details - K110051

510(k) Number K110051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2011
Decision Date February 02, 2012
Days to Decision 391 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
266d slower than avg
Panel avg: 125d · This submission: 391d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 462
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K110051.
GORE DRYSEAL SHEATH
K120428 · W.L. Gore & Associates, Inc. · Apr 2012
SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
K112407 · Smiths Medical MD, Inc. · Feb 2012
VASCULAR SONO
K113196 · PAJUNK GmbH Medizintechnologie · Feb 2012
TRANSRADIAL ARTERY ACCESS DEVICES
K112554 · Teleflexmedical, Inc. · Nov 2011
PINNACLE PRECISION ACCESS SYSTEM
K111606 · Terumo Medical Corp. · Oct 2011
ENGAGE/ENGAGE TR INTRODUCERS
K111092 · St Jude Medical · Jun 2011