Cleared Traditional

K161700 - SoundStar eco 8F 3D Diagnostic eco Ultr...

K161700 is the FDA 510(k) clearance for SoundStar eco 8F 3D Diagnostic eco Ultr... by Sterilmed, Inc.. It is a Class 2 Cardiovascular device (product code OWQ) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K161700 · Sterilmed, Inc. · Cardiovascular device
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Nov 2016
Decision
154d
Days
Class 2
Risk

K161700 is an FDA 510(k) clearance for the SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3.... Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 21, 2016 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Sterilmed, Inc. devices

Submission Details

510(k) Number K161700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2016
Decision Date November 21, 2016
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWQ Reprocessed Intravascular Ultrasound Catheter
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 - OWQ Reprocessed Intravascular Ultrasound Catheter

All 26
Devices cleared under the same product code (OWQ) and FDA review panel - the closest regulatory comparables to K161700.
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K173262 · Innovative Health, LLC · Mar 2018
Reprocessed AcuNav Diagnostic Ultrasound Catheter
K163560 · Innovative Health, LLC · Jul 2017
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
K170474 · Innovative Health, LLC · Jun 2017
Reprocessed Diagnostic Ultrasound Catheter
K153090 · Innovative Health, LLC · Mar 2016
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
K110076 · Sterilmed, Inc. · Aug 2011
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
K033436 · Alliance Medical Corp. · Mar 2005