Cleared Traditional

K192211 - SoundBite Console

K192211 is the FDA 510(k) clearance for SoundBite Console by Soundbite Medical Solution, Inc.. It is a Class 2 Cardiovascular device (product code PDU) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K192211 · Soundbite Medical Solution, Inc. · Cardiovascular device
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Jan 2020
Decision
156d
Days
Class 2
Risk

K192211 is an FDA 510(k) clearance for the SoundBite Console, SoundBite Active Wire 18. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Soundbite Medical Solution, Inc. (Montreal, CA). The FDA issued a Cleared decision on January 17, 2020 after a review of 156 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Soundbite Medical Solution, Inc. devices

Submission Details

510(k) Number K192211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2019
Decision Date January 17, 2020
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.
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 - PDU Catheter For Crossing Total Occlusions

All 23
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K192211.
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
K210664 · Ra Medical Systems,Inc · Jul 2021
SoundBite Crossing System - Peripheral (14P)
K210839 · Soundbite Medical Solutions, Inc. · Apr 2021
Tigereye CTO-Crossing Catheter
K201330 · Avinger, Inc. · Sep 2020
XableCath Crossing Catheter
K183357 · Xablecath, Inc. · Jan 2019
TRUEPATH CTO DEVICE
K140288 · Boston Scientific Corp · Apr 2014
OFFROAD RE-ENTRY CATHETER SYSTEM
K131914 · Boston Scientific Corp · Oct 2013