Cleared Traditional

K230604 - IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)

K230604 is an FDA 510(k) clearance for IntelliVue Patient Monitor MX100 (867033), manufactured by Philips Medizin Systeme Boeblingen GmbH. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K230604 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
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Nov 2023
Decision
264d
Days
Class 2
Risk

K230604 is an FDA 510(k) clearance for the IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Modul.... 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 November 22, 2023 after a review of 264 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

FDA 510(k) Submission Details - K230604

510(k) Number K230604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2023
Decision Date November 22, 2023
Days to Decision 264 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
139d slower than avg
Panel avg: 125d · This submission: 264d
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 398
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K230604.
Patient Monitor (iX10, iX12, iX15)
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Central Monitoring System (MFM-CMS)
K232694 · Edan Instruments, Inc. · Feb 2024
IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
K231671 · Philips Medizin Systeme Boeblingen GmbH · Dec 2023
Infinity CentralStation Wide, Infinity M300, Infinity M300+
K231477 · Draeger Medical Systems, Inc. · Oct 2023
IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
K223574 · Philips Medizin Systeme Boeblingen GmbH · Aug 2023
ARGUS PB-3000
K221056 · Schiller AG · Jul 2023