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

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Nov 22, 2023 after 264 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 40 generations back to K941811 (1994). 270 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 272 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182979: IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3, Philips Medizin Systeme Boeblingen GmbH (2019) Summary page 6.

## Most influential descendants
- K252726: IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) (2026), 0 descendants of its own

## Indications for use
Intended Use: The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. Indication for Use: The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor is only for use on one patient at a time. The monitor is not a therapeutic device. Caution: The monitor is for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The Integrated Pulmonary Index (IPl) is intended for use with adult and pediatric (1 to 12 years) patients only. Warning: The IPl is an adjunct to and not intended to replace vital sign monitoring. The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients. The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused. The monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside the hospital environment. It is not intended for home use. Warning: The monitor is not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers). Contraindications: There are no known contraindications for the IntelliVue MX100/X3 Patient Monitor/Multi-Measurement Module.

Source page: https://510kreport.com/device/K230604
Methodology: https://510kreport.com/methodology