Cleared Traditional

RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT (K110051) - FDA 510(k) Clearance

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

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.

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Submission Details

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.

Device Classification

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 313
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K110051.
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
K121185 · Edwards Lifesciences, LLC · Aug 2012
PRELUDE 7F SHORT SHEATH INTRODUCER
K122190 · Merit Medical Systems, Inc. · Aug 2012
GORE DRYSEAL SHEATH
K120428 · W.L. Gore & Associates, Inc. · Apr 2012
PINNACLE PRECISION ACCESS SYSTEM
K111606 · Terumo Medical Corp. · Oct 2011
ENGAGE/ENGAGE TR INTRODUCERS
K111092 · St Jude Medical · Jun 2011
AGILIS NXT STEERABLE INTRODUCER
K110450 · St Jude Medical · May 2011