Cleared Special

MX40 Release C.01 (K180017) - FDA 510(k) Clearance

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

K180017 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
203d
Days
Class 2
Risk

K180017 is an FDA 510(k) clearance for the MX40 Release C.01. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on July 24, 2018 after a review of 203 days - an extended review 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. Standard predicate reliance. 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 Medical Systems devices

Submission Details

510(k) Number K180017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2018
Decision Date July 24, 2018
Days to Decision 203 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
78d slower than avg
Panel avg: 125d · This submission: 203d
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 196
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K180017.
Surveyor Patient Monitor
K173765 · Mortara Instrument, Inc. · Sep 2018
IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
K181314 · Philips Medizin Systeme Boeblingen GmbH · Sep 2018
Multi-parameter Patient Monitor, models C30
K173454 · Shenzhen Comen Medical Instruments Co.,Ltd · Aug 2018
ViSi Mobile Monitoring System
K180472 · Sotera Wireless, Inc. · Jun 2018
µCor Heart Failure and Arrhythmia Management System
K172510 · Zoll Manufacturing Corporation · May 2018
Tempus Pro Patient Monitor
K173768 · Remote Diagnostic Technologies , Ltd. · Jan 2018