Cleared Traditional

K152498 - SoloPath Re-Collapsible Access System

K152498 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 126-day FDA review.

K152498 · Onset Medical Corporation · Cardiovascular device
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Jan 2016
Decision
126d
Days
Class 2
Risk

K152498 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 January 5, 2016 after a review of 126 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. 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. Standard predicate reliance. 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 - K152498

510(k) Number K152498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2015
Decision Date January 05, 2016
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 125d · This submission: 126d
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 Consultant

Terumo Corporation
Monika McDole-Russell

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 - DYB Introducer, Catheter

All 646
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K152498.
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Glidesheath
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K152225 · Edwards Lifesciences · Nov 2015