Cleared Special

K050742 - M3290A INTELLIVUE INFORMATION CENTER SO...

K050742 is the FDA 510(k) clearance for M3290A INTELLIVUE INFORMATION CENTER SO... by Philips Medical Systems. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Special 510(k) pathway after a 14-day FDA review.

K050742 · Philips Medical Systems · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2005
Decision
14d
Days
Class 2
Risk

K050742 is an FDA 510(k) clearance for the M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00. 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 April 5, 2005 after a review of 14 days - a notably fast clearance 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. Low regulatory complexity profile. 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 K050742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2005
Decision Date April 05, 2005
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
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 275
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K050742.
INFINITY MONITORS WITH SCIO MODIFICATIONS
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PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90
K050762 · Philips Medizin Systeme Boeblingen GmbH · Apr 2005
INFINITY KAPPA XLT
K042904 · Draeger Medical Systems, Inc. · Feb 2005
INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL
K043439 · Draeger Medical Systems, Inc. · Feb 2005
DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES
K043551 · Datex-Ohmeda · Feb 2005