Cleared Special

K102562 - INTELLIVUE PATIENT MONITOR

K102562 is an FDA 510(k) clearance for INTELLIVUE PATIENT MONITOR, manufactured by Philips Medizin Systeme Boblingen GmbH. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 44-day FDA review.

K102562 · Philips Medizin Systeme Boblingen GmbH · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2010
Decision
44d
Days
Class 2
Risk

K102562 is an FDA 510(k) clearance for the INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50.... Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boblingen GmbH (Boblingen, DE). The FDA issued a Cleared decision on October 21, 2010 after a review of 44 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 Boblingen GmbH devices

FDA 510(k) Submission Details - K102562

510(k) Number K102562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2010
Decision Date October 21, 2010
Days to Decision 44 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · This submission: 44d
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 332
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K102562.
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K102495 · Philips Medical Systems · Sep 2010
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K102040 · Guangdong Biolight Meditech Co., Ltd. · Sep 2010