Cleared Traditional

K221348 - IntelliVue Patient Monitor MX750 (866471)

Also marketed or referenced as:
IntelliVue Patient Monitor MX850 (866470)

K221348 is an FDA 510(k) clearance for IntelliVue Patient Monitor MX750 (866471), 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 270-day FDA review.

K221348 · Philips Medizin Systeme B?blingen GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
270d
Days
Class 2
Risk

K221348 is an FDA 510(k) clearance for the IntelliVue Patient Monitor MX750 (866471). 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 (Boeblingen, DE). The FDA issued a Cleared decision on February 3, 2023 after a review of 270 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 - K221348

510(k) Number K221348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2022
Decision Date February 03, 2023
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 125d · This submission: 270d
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)

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