Cleared Traditional

IntelliVue Patient monitors MX400, MX450, MX500, MX550

K251146 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular
Oct 2025
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K251146 is an FDA 510(k) clearance for the IntelliVue Patient monitors MX400, MX450, MX500, MX550, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Philips Medizin Systeme Boeblingen GmbH (B?blingen, DE). The FDA issued a Cleared decision on October 17, 2025, 186 days after receiving the submission on April 14, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K251146 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2025
Decision Date October 17, 2025
Days to Decision 186 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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