Cleared Traditional

K251146 - IntelliVue Patient monitors MX400

K251146 is the FDA 510(k) clearance for IntelliVue Patient monitors MX400 by Philips Medizin Systeme Boeblingen GmbH. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

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

K251146 is an FDA 510(k) clearance for the IntelliVue Patient monitors MX400, MX450, MX500, MX550. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Böblingen, DE). The FDA issued a Cleared decision on October 17, 2025 after a review of 186 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medizin Systeme Boeblingen GmbH devices

Submission Details

510(k) Number K251146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 125d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 274
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K251146.
Corvair Monza
K252589 · AliveCor, Inc. · Jan 2026
Multi-parameter Patient Monitor (N10)
K250854 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025
IntelliVue Patient Monitor MX750
K251702 · Philips Medizin Systeme B?blingen GmbH · Nov 2025
IntelliVue Patient Monitor 6100 (6100)
K250453 · Philips Medizin Systeme B?blingen GmbH · Sep 2025
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
K250179 · Edan Instruments, Inc. · Jul 2025
Monitor B105M
K242562 · Ge Medical Systems Information Technologies, Inc. · Jul 2025