Cleared Traditional

K230604 - IntelliVue Patient Monitor MX100 (867033)

K230604 is the FDA 510(k) clearance for IntelliVue Patient Monitor MX100 (867033) 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 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

Submission Details

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.

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 K230604.
Patient Monitor (iX10, iX12, iX15)
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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