Cleared Special

IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2 (K161531) - FDA 510(k) Clearance

Also marketed or referenced as:
IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60 IntelliVue Patient Monitors MP70, MP80, MP90 IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600 IntelliVue Patient Monitors MX700, MX800

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

K161531 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
29d
Days
Class 2
Risk

K161531 is an FDA 510(k) clearance for the IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Modu.... 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 July 1, 2016 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Philips Medizin Systeme Boeblingen GmbH devices

Submission Details

510(k) Number K161531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2016
Decision Date July 01, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K161531.
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K153160 · Medtronic, Inc. · Mar 2016
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO
K031340 · Siemens Medical Solutions USA, Inc. · Nov 2003
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K030738 · Siemens Medical Solutions USA, Inc. · Jun 2003