Cleared Traditional

K181126 - Reprocessed Visions PV .035 Digital IVU...

K181126 is the FDA 510(k) clearance for Reprocessed Visions PV .035 Digital IVU... by Innovative Health, LLC. It is a Class 2 Cardiovascular device (product code OWQ) cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K181126 · Innovative Health, LLC · Cardiovascular device
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Jan 2019
Decision
263d
Days
Class 2
Risk

K181126 is an FDA 510(k) clearance for the Reprocessed Visions PV .035 Digital IVUS Catheter. Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on January 18, 2019 after a review of 263 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 Innovative Health, LLC devices

Submission Details

510(k) Number K181126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2018
Decision Date January 18, 2019
Days to Decision 263 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
138d slower than avg
Panel avg: 125d · This submission: 263d
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 K181126.
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K202042 · Innovative Health, LLC · Nov 2020
Reprocessed ViewFlex™ Xtra ICE Catheter
K190478 · Sterilmed, Inc. · Nov 2019
Reprocessed ViewFlex Xtra ICE Catheter
K182238 · Stryker Sustainability Solutions · May 2019
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