Cleared Special

K050762 - PHILIPS INTELLIVUE PATIENT MONITOR

K050762 is the FDA 510(k) clearance for PHILIPS INTELLIVUE PATIENT MONITOR by Philips Medizin Systeme Boeblingen GmbH. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Special 510(k) pathway after a 29-day FDA review.

K050762 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
29d
Days
Class 2
Risk

K050762 is an FDA 510(k) clearance for the PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70.... Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, Bw, DE). The FDA issued a Cleared decision on April 22, 2005 after a review of 29 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 Medizin Systeme Boeblingen GmbH devices

Submission Details

510(k) Number K050762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2005
Decision Date April 22, 2005
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 300
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K050762.
M3046B COMPACT PORTABLE PATIENT MONITORS
K052707 · Philips Medical Systems · Oct 2005
INFINITY MONITORS WITH SCIO MODIFICATIONS
K051628 · Draeger Medical Systems, Inc. · Jul 2005
PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000
K051367 · Ge Medical Systems Information Technologies · Jun 2005
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00
K050742 · Philips Medical Systems · 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