Cleared Special

K061610 - PHILIPS MODEL MP20

K061610 is the FDA 510(k) clearance for PHILIPS MODEL MP20 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 66-day FDA review.

K061610 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
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Aug 2006
Decision
66d
Days
Class 2
Risk

K061610 is an FDA 510(k) clearance for the PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PA.... 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 August 14, 2006 after a review of 66 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 K061610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2006
Decision Date August 14, 2006
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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)

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