# K171801: IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Oct 6, 2017 after 112 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 37 generations back to K941811 (1994). 266 ancestors in all.
8 later devices descend from it; 3 cite it directly.
1 of 275 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161531: IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800, Philips Medizin Systeme Boeblingen GmbH (2016) Summary page 6.
- K033444: Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement Server, Philips Medical Systems (2003) Summary page 6.
- K061573: Transpac Iii Disposable Straight Pressure Transducer and Kit, Hospira, Inc. (2006) Summary page 6.

## Most influential descendants
- K181314: IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension (2018), 6 descendants of its own
- K182979: IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 (2019), 5 descendants of its own
- K223574: IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) (2023), 2 descendants of its own
- K230604: IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) (2023), 1 descendant of its own
- K252726: IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) (2026), 0 descendants of its own

## Recalls of this device
- Oct 31, 2025 · Class II · Z-0860-2026: Potential issue where the IntelliVue monitors did not alarm.
- Oct 31, 2025 · Class II · Z-0861-2026: Potential issue where the IntelliVue monitors did not alarm.
- Nov 17, 2017 · Class II · Z-1315-2018: The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, w
- Oct 5, 2017 · Class II · Z-0850-2018: Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defective component, which may result in loss of connection to the Information Center iX. The 

## Indications 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 intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. 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. The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. 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 EC 11). 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 (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring. 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 measurement extension adds physiological measurements to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals. The measurement extension can only function when it is connected to a dedicated host device.

Source page: https://510kreport.com/device/K171801
Methodology: https://510kreport.com/methodology