Cleared Traditional

K110076 - REPROCESSED 3D DIAGNOSTIC ULTRASOUND CA...

K110076 is the FDA 510(k) clearance for REPROCESSED 3D DIAGNOSTIC ULTRASOUND CA... by Sterilmed, Inc.. It is a Class 2 Cardiovascular device (product code OWQ) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K110076 · Sterilmed, Inc. · Cardiovascular device
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Aug 2011
Decision
219d
Days
Class 2
Risk

K110076 is an FDA 510(k) clearance for the REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER. Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 18, 2011 after a review of 219 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 K110076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2011
Decision Date August 18, 2011
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
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 K110076.
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
K170474 · Innovative Health, LLC · Jun 2017
SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
K161700 · Sterilmed, Inc. · Nov 2016
Reprocessed Diagnostic Ultrasound Catheter
K153090 · Innovative Health, LLC · Mar 2016
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
K033436 · Alliance Medical Corp. · Mar 2005
STERILEMED REPROCESSED IVUS IMAGING CATHETER
K043453 · Sterilmed, Inc. · Mar 2005
REPROCESSED IMAGING CATHETERS
K012537 · Sterilmed, Inc. · Oct 2002