Cleared Special

K181042 - Ultra ICE Plus – PI 9 MHz Peripheral Im...

K181042 is the FDA 510(k) clearance for Ultra ICE Plus – PI 9 MHz Peripheral Im... by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (product code DXK) cleared through the Special 510(k) pathway after a 28-day FDA review.

K181042 · Boston Scientific Corporation · Cardiovascular device
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May 2018
Decision
28d
Days
Class 2
Risk

K181042 is an FDA 510(k) clearance for the Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on May 17, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K181042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2018
Decision Date May 17, 2018
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 - DXK Echocardiograph

All 35
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K181042.
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
K160173 · Boston Scientific Corporation · Feb 2016
ACCESSORY TO GENESIS III (GCFM)
K913209 · Biosound, Inc. · May 1992
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · Hewlett-Packard Co. · Apr 1991
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
K910029 · Spacelabs, Inc. · Jan 1991
DOPPLER OPTION FOR PLATINUM
K900002 · Philips Medical Systems North America, Inc. · Apr 1990
ULTRAMARK 7 ULTRASOUND SYSTEM
K896543 · Advanced Technology Laboratories, Inc. · Feb 1990