Cleared Traditional

K210655 - Reprocessed Eagle Eye Platinum RX Digit...

K210655 is the FDA 510(k) clearance for Reprocessed Eagle Eye Platinum RX Digit... by Innovative Health, LLC. It is a Class 2 Cardiovascular device (product code OWQ) cleared through the Traditional 510(k) pathway after a 447-day FDA review.

K210655 · Innovative Health, LLC · Cardiovascular device
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May 2022
Decision
447d
Days
Class 2
Risk

K210655 is an FDA 510(k) clearance for the Reprocessed Eagle Eye Platinum RX 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 May 25, 2022 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Innovative Health, LLC devices

Submission Details

510(k) Number K210655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2021
Decision Date May 25, 2022
Days to Decision 447 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
322d slower than avg
Panel avg: 125d · This submission: 447d
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 K210655.
ViewFlex™ Eco Reprocessed ICE Catheter
K230934 · Abbott Medical · May 2023
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K223026 · Northeast Scientific, Inc. · Feb 2023
ViewFlex Xtra Reprocessed ICE Catheter
K222217 · Abbott Medical · Dec 2022
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