IntelliVue Patient monitors MX400, MX450, MX500, MX550 (K251146): 510(k) cleared Oct 17, 2025

IntelliVue Patient monitors MX400, MX450, MX500, MX550

Philips Medizin Systeme Boeblingen GmbH · Oct 17, 2025 · K251146

FDA cleared the IntelliVue Patient monitors MX400, MX450, MX500, MX550 from Philips Medizin Systeme Boeblingen GmbH on Oct 17, 2025 under K251146, a traditional 510(k). The device falls under product code MHX, Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 14, 2025. The decision came 186 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Philips Medizin Systeme Boeblingen GmbH has 5 other decisions in the tracker over the last 12 months: K252821 (Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)), K253887 (Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)), K253654 (IntelliVue Measurement Rack 6000 (867317)), K252726 (IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)).

Questions & Answers

What did FDA clear under K251146?

K251146 is the FDA 510(k) for IntelliVue Patient monitors MX400, MX450, MX500, MX550, submitted by Philips Medizin Systeme Boeblingen GmbH. FDA's decision date was Oct 17, 2025, under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)).

Who makes the IntelliVue Patient monitors MX400, MX450, MX500, MX550?

Philips Medizin Systeme Boeblingen GmbH, based in Böblingen, is the applicant of record for K251146.

How long did the K251146 review take?

FDA received the submission on Apr 14, 2025 and issued its decision on Oct 17, 2025, 186 days later.

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