Cleared Traditional

K172226 - MX40 Release B.07

K172226 is an FDA 510(k) clearance for MX40 Release B.07, manufactured by Philips Medical Systems. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K172226 · Philips Medical Systems · Cardiovascular device
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Nov 2017
Decision
107d
Days
Class 2
Risk

K172226 is an FDA 510(k) clearance for the MX40 Release B.07. 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 November 9, 2017 after a review of 107 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 Medical Systems devices

FDA 510(k) Submission Details - K172226

510(k) Number K172226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2017
Decision Date November 09, 2017
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

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 398
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K172226.
Tempus Pro Patient Monitor
K173768 · Remote Diagnostic Technologies , Ltd. · Jan 2018
CMS-2000 Central Monitoring System
K172966 · Advanced Instumentations, Inc. · Dec 2017
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
K171901 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2017
Monitor B125, Monitor B105
K171580 · Ge Medical Systems China Co., Ltd. · Nov 2017
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3
K171801 · Philips Medizin Systeme Boeblingen GmbH · Oct 2017
Passport Series Patient Monitors(Passport 12m, Passport 17m)
K170876 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2017