Cleared Traditional

K163584 - M3290B Philips IntelliVue Information C...

K163584 is the FDA 510(k) clearance for M3290B Philips IntelliVue Information C... by Philips Medical Systems. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 275
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K163584.
MX40 Release B.07
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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
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
K171621 · Welch Allyn, Inc. · Jun 2017
Telemetry Transmitter
K161056 · Edan Instruments, Inc. · Feb 2017
Mortara Surveyor Patient Monitor
K161517 · Mortara Instrument, Inc. · Jan 2017