Cleared Traditional

IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)

K252726 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular
Feb 2026
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K252726 is an FDA 510(k) clearance for the IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036), 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 February 6, 2026, 162 days after receiving the submission on August 28, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K252726 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2025
Decision Date February 06, 2026
Days to Decision 162 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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