Cleared Special

K101449 - INTELLIVUE PATIENT MONITOR

K101449 is an FDA 510(k) clearance for INTELLIVUE PATIENT MONITOR, manufactured by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 25-day FDA review.

K101449 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular device
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Jun 2010
Decision
25d
Days
Class 2
Risk

K101449 is an FDA 510(k) clearance for the INTELLIVUE PATIENT MONITOR. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, DE). The FDA issued a Cleared decision on June 18, 2010 after a review of 25 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 Medizinsysteme Boeblingen GmbH, Cardiac AN devices

FDA 510(k) Submission Details - K101449

510(k) Number K101449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2010
Decision Date June 18, 2010
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K101449.
PATIENT MONITOR
K102040 · Guangdong Biolight Meditech Co., Ltd. · Sep 2010
BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
K092449 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2010
ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
K101521 · Philips Medical Systems · Jul 2010
INTELLIVUE PATIENT MONITOR
K093268 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · May 2010
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068
K101067 · Philips Medical Systems · May 2010
INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90
K100939 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Apr 2010