Cleared Special

K181042 - Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

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

K181042 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K181042

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.

DXK Device Classification - Class 2, Special Controls

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 77
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
IN-VISION IMAGING SYSTEM
K031148 · Jomed, Inc. · May 2003
9750 ATHENA ETHERNET OPTION
K934887 · S & W Medico Teknik A/S · Jan 1994
ACCESSORY TO GENESIS III (GCFM)
K913209 · Biosound, Inc. · May 1992
CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
K911384 · Endosonics Corp. · Jun 1991
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · Hewlett-Packard Co. · Apr 1991
K181042 · Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
Download PDF FDA Summary Boston Scientific Cor…