Cleared Traditional

SonoStik IV Guide Wire Introducer (K152177) - FDA 510(k) Clearance

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

K152177 · Sonostik, LLC · Cardiovascular device
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Oct 2015
Decision
58d
Days
Class 2
Risk

K152177 is an FDA 510(k) clearance for the SonoStik IV Guide Wire Introducer. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Sonostik, LLC (N Potomac, US). The FDA issued a Cleared decision on October 1, 2015 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sonostik, LLC devices

Submission Details

510(k) Number K152177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2015
Decision Date October 01, 2015
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
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 279
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K152177.
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