Cleared Traditional

K163584 - M3290B Philips IntelliVue Information Center iX

K163584 is an FDA 510(k) clearance for M3290B Philips IntelliVue Information C..., 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 199-day FDA review.

K163584 · Philips Medical Systems · Cardiovascular device
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Jul 2017
Decision
199d
Days
Class 2
Risk

K163584 is an FDA 510(k) clearance for the M3290B Philips IntelliVue Information Center iX. 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 7, 2017 after a review of 199 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. 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 - K163584

510(k) Number K163584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2016
Decision Date July 07, 2017
Days to Decision 199 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
74d slower than avg
Panel avg: 125d · This submission: 199d
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 K163584.
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
Tempus Pro Patient Monitor
K170567 · Remote Diagnostic Technologies , Ltd. · Jul 2017
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
K171621 · Welch Allyn, Inc. · Jun 2017
EK12 Algorithm
K170155 · Ge Medical Systems Information Technologies, Inc. · Jun 2017