Cleared Traditional

K121404 - SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM

K121404 is an FDA 510(k) clearance for SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM, manufactured by Onset Medical Corporation. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K121404 · Onset Medical Corporation · Cardiovascular device
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May 2013
Decision
358d
Days
Class 2
Risk

K121404 is an FDA 510(k) clearance for the SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM. 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 May 3, 2013 after a review of 358 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 Onset Medical Corporation devices

FDA 510(k) Submission Details - K121404

510(k) Number K121404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2012
Decision Date May 03, 2013
Days to Decision 358 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
233d slower than avg
Panel avg: 125d · This submission: 358d
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 410
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K121404.
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SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
K123990 · Medtronic Vascular · Apr 2013
EQUAFLOW MULTIVALVE INFUSION CATHETER
K123235 · Cook Incorporated · Feb 2013
SUREFLEX STEERABLE GUIDING SHEATH KIT
K122926 · Baylis Medical Co., Inc. · Jan 2013