Cleared Traditional

K153702 - M3290B Philips IntelliVue Information C...

K153702 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 173-day FDA review.

K153702 · Philips Medical Systems · Cardiovascular device
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Jun 2016
Decision
173d
Days
Class 2
Risk

K153702 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 June 13, 2016 after a review of 173 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 - K153702

510(k) Number K153702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date June 13, 2016
Days to Decision 173 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
48d slower than avg
Panel avg: 125d · This submission: 173d
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 331
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K153702.
Nihon Kohden Vital Sign Telemeter
K153707 · Nihon Kohden Corporation · Sep 2016
Surveyor S4 Mobile Monitor
K160685 · Mortara Instrument, Inc. · Aug 2016
IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2
K161531 · Philips Medizin Systeme Boeblingen GmbH · Jul 2016
Philips Efficia CMS200 Central Monitoring System
K160951 · Philips Medical Systems · May 2016
Patient Monitor
K152552 · Edan Instruments, Inc. · Apr 2016
AVIVO Mobile Patient Management (MPM) System
K153160 · Medtronic, Inc. · Mar 2016