Cleared Special

PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS (K041235) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041235 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
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Jun 2004
Decision
24d
Days
Class 2
Risk

K041235 is an FDA 510(k) clearance for the PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS. 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 June 4, 2004 after a review of 24 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 K041235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2004
Decision Date June 04, 2004
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
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 106
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