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Physiological Monitor, Patient Monitor

by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

510(k) K113441

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K113441; other models may be affected

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 · Traditional NumberK113441 Date22 Mar 2012ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1722-2025 FDA Class II initiated 7 Apr 2025 on shared 510(k) K113441

    Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
MHX
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a physiological patient monitor, classified as a Class II medical device under FDA regulations. It is designed to continuously monitor and display vital signs such as ECG, blood pressure, pulse oximetry, respiratory rate, and other physiological parameters. The monitor includes arrhythmia detection and alarm capabilities to alert clinicians to critical changes in patient status, supporting real-time clinical decision-making in acute care settings.

The IntelliVue Patient Monitor is intended for use in hospital environments, including intensive care units (ICUs), emergency departments, and operating rooms. It is supplied as a reusable device and requires proper sterilization and maintenance protocols to ensure patient safety and device functionality. The monitor is MRI-safe under specific conditions and is available in multiple models (e.g., MX400, MX450, MX500) with varying features and configurations. Authorized under FDA 510(k) clearance, it adheres to regulatory standards for cardiovascular monitoring devices.

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Questions

AI-generated answers, 1 Oct 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 settings is the IntelliVue Patient Monitor intended for?

    The IntelliVue Patient Monitor is specifically designed for acute care environments where continuous patient monitoring is critical. This includes intensive care units (ICUs), emergency departments, and operating rooms. Its ability to display vital signs such as ECG, blood pressure, pulse oximetry, and respiratory rate makes it ideal for high-acuity areas where clinicians need immediate access to patient status updates. The monitor’s alarm capabilities further support real-time clinical decision-making in these settings.

  • How is the IntelliVue Patient Monitor supplied and maintained?

    The IntelliVue Patient Monitor is supplied as a reusable device. To ensure patient safety and device functionality, it requires adherence to strict sterilization and maintenance protocols. These protocols are essential to prevent cross-contamination and to maintain the monitor’s performance over repeated use. Philips Medizinsysteme Boeblingen GmbH provides guidelines for proper cleaning, disinfection, and servicing to support long-term reliability.

  • Does the IntelliVue Patient Monitor come in different models, and what distinguishes them?

    Yes, the IntelliVue Patient Monitor is available in multiple models, including the MX400, MX450, and MX500. Each model may offer varying features and configurations tailored to specific clinical needs. For example, the MX400 serves as a foundational model, while others like the MX450 or MX500 may include additional functionalities or enhanced display options. The choice of model depends on the clinical environment’s requirements, such as the need for advanced monitoring capabilities or expanded connectivity.

  • Is the IntelliVue Patient Monitor safe for use in MRI environments?

    The IntelliVue Patient Monitor is designed to be MRI-safe under specific conditions. However, the exact parameters for MRI compatibility, such as the maximum magnetic field strength and safe distance from the MRI scanner, must be reviewed in the device’s technical documentation or user manual. Clinicians should ensure compliance with these conditions to avoid compromising patient safety or device functionality during MRI procedures.

  • What regulatory pathway was followed for the FDA clearance of this device?

    The IntelliVue Patient Monitor received FDA clearance through a 510(k) submission, which is a traditional pathway for demonstrating that the device is substantially equivalent to a legally marketed predicate device. The submission was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee, and the decision was classified as substantially equivalent (SESE). This pathway ensures that the monitor meets regulatory standards for cardiovascular monitoring devices while maintaining safety and effectiveness for its intended use.