Cleared Traditional

K251702 - IntelliVue Patient Monitor MX750

Also marketed or referenced as:
IntelliVue Patient Monitor MX850 IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )

K251702 is an FDA 510(k) clearance for IntelliVue Patient Monitor MX750, manufactured by Philips Medizin Systeme B?blingen GmbH. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K251702 · Philips Medizin Systeme B?blingen GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
161d
Days
Class 2
Risk

K251702 is an FDA 510(k) clearance for the IntelliVue Patient Monitor MX750. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Philips Medizin Systeme B?blingen GmbH (Böblingen, DE). The FDA issued a Cleared decision on November 10, 2025 after a review of 161 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 B?blingen GmbH devices

FDA 510(k) Submission Details - K251702

510(k) Number K251702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2025
Decision Date November 10, 2025
Days to Decision 161 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
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

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 319
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K251702.
IntelliVue Multi-Measurement Module X3 (867030)
K252726 · Philips Medizin Systeme Boeblingen GmbH · Feb 2026
Corvair Monza
K252589 · AliveCor, Inc. · Jan 2026
Multi-parameter Patient Monitor (N10)
K250854 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025
IntelliVue Patient monitors MX400, MX450, MX500, MX550
K251146 · Philips Medizin Systeme Boeblingen GmbH · Oct 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