Cleared Special

K100819 - THE SOLOPATH BALLOON EXPANDABLE TRANSFE...

K100819 is an FDA 510(k) clearance for THE SOLOPATH BALLOON EXPANDABLE TRANSFE..., manufactured by Onset Medical Corporation. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 132-day FDA review.

K100819 · Onset Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
132d
Days
Class 2
Risk

K100819 is an FDA 510(k) clearance for the THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Onset Medical Corporation (Irvine, US). The FDA issued a Cleared decision on August 2, 2010 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Onset Medical Corporation devices

FDA 510(k) Submission Details - K100819

510(k) Number K100819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2010
Decision Date August 02, 2010
Days to Decision 132 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Modification to existing cleared device.

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 410
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K100819.
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6F ENGAGE/ENGAGE TR INTRODUCER
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GLIDESHEATH
K102008 · Terumo Medical Corp. · Jul 2010
RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
K093877 · Edwards Lifesciences, LLC · Jul 2010
GORE DRYSEAL SHEATH
K093791 · W.L. Gore & Associates, Inc. · Mar 2010