Cleared Special

K092064 - SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12

K092064 is an FDA 510(k) clearance for SOUNDSTAR 3D ULTRASOUND CATHETER, manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code OBJ cleared through the Special 510(k) pathway after a 30-day FDA review.

K092064 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
30d
Days
Class 2
Risk

K092064 is an FDA 510(k) clearance for the SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K092064

510(k) Number K092064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2009
Decision Date August 07, 2009
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

OBJ Device Classification - Class 2, Special Controls

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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 - OBJ Catheter, Ultrasound, Intravascular

All 79
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K092064.
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
K101138 · Biosense Webster, Inc. · Jun 2010
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K092596 · Volcano Corporation · Dec 2009
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05
K091352 · Biosense Webster, Inc. · Dec 2009
FLOWPICC CONSOLE
K081626 · Vasonova, Inc. · Oct 2008
FLOWPICC STYLET
K081625 · Vasonova, Inc. · Sep 2008
ACUNAV V ULTRASOUND CATHETER
K081808 · Siemens Medical Solutions USA, Inc. · Sep 2008
K092064 · SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12
Download PDF FDA Summary Biosense Webster, Inc.