Cleared Traditional

IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension (K181314) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181314 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
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Sep 2018
Decision
110d
Days
Class 2
Risk

K181314 is an FDA 510(k) clearance for the IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, Int.... Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Böblingen, DE). The FDA issued a Cleared decision on September 4, 2018 after a review of 110 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 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 Philips Medizin Systeme Boeblingen GmbH devices

Submission Details

510(k) Number K181314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2018
Decision Date September 04, 2018
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 102
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K181314.
ZOLL Propaq M
K180482 · ZOLL Medical Corporation · Nov 2018
IntelliVue Multi-Measurement Module MMX
K181831 · Philips Medizin Systeme Boeblingen GmbH · Nov 2018
Surveyor Patient Monitor
K173765 · Mortara Instrument, Inc. · Sep 2018
Multi-parameter Patient Monitor, models C30
K173454 · Shenzhen Comen Medical Instruments Co.,Ltd · Aug 2018
MX40 Release C.01
K180017 · Philips Medical Systems · Jul 2018
ViSi Mobile Monitoring System
K180472 · Sotera Wireless, Inc. · Jun 2018