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INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS - MP60

by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

510(k) K082633

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK082633 Date3 Oct 2008ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0544-2021 FDA Class II initiated 18 Nov 2020

    Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.

    • Terminated Z-2625-2010 FDA Unclassified (pre-2012) initiated 31 Aug 2010

    Speakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment.

    • Terminated Z-0817-2009 FDA Unclassified (pre-2012) initiated 22 Oct 2008

    Table Mounts assembled with incorrect length hardware may fall

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DSI
Models / Variants
MP60
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a detector and alarm for arrhythmia, classified as a cardiovascular medical device under regulation number 870.1025. It is designed for monitoring and recording multiple physiological parameters and generating alarms for adults, pediatrics, and neonates in hospital environments.

The device is supplied as a reusable patient monitor system comprising models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90. It received FDA 510(k) clearance (K082633) on October 3, 2008, and is manufactured by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN in Boeblingen, Germany.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical purpose does the IntelliVue XDS monitor serve?

    It functions as a detector and alarm for arrhythmia while simultaneously monitoring and recording a range of physiological parameters. This enables clinicians to track heart rhythm and other vital signs in real time for adult, pediatric and neonatal patients in hospital settings.

  • How is the IntelliVue XDS supplied to users?

    The device is provided as a reusable patient‑monitor system. Hospitals receive the complete monitor unit, and the same hardware can be used repeatedly across patients, provided it is cleaned and maintained according to the manufacturer’s guidelines.

  • Which models are included in the IntelliVue XDS family?

    The XDS family comprises ten models: MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90. Each model shares the same core arrhythmia‑detection and multi‑parameter monitoring capabilities, allowing facilities to select the size and feature set that best fits their clinical workflow.

  • What regulatory pathway did the IntelliVue XDS follow?

    The monitor received FDA 510(k) clearance (K082633) on October 3 2008, indicating it was found substantially equivalent to a legally marketed predicate device. The clearance was classified under device class 2 for cardiovascular use, specifically as a detector and alarm for arrhythmia.