Cleared Abbreviated

IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 (K171801) - FDA 510(k) Clearance

Also marketed or referenced as:
intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension Transpac IV Dual IBP Cable

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K171801 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
112d
Days
Class 2
Risk

K171801 is an FDA 510(k) clearance for the IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on October 6, 2017 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medizin Systeme Boeblingen GmbH devices

Submission Details

510(k) Number K171801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2017
Decision Date October 06, 2017
Days to Decision 112 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 103
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K171801.
Tempus Pro Patient Monitor
K173768 · Remote Diagnostic Technologies , Ltd. · Jan 2018
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
K171901 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2017
MX40 Release B.07
K172226 · Philips Medical Systems · Nov 2017
Passport Series Patient Monitors(Passport 12m, Passport 17m)
K170876 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2017
M3290B Philips IntelliVue Information Center iX
K163584 · Philips Medical Systems · Jul 2017
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
K171621 · Welch Allyn, Inc. · Jun 2017