# K150310: IntelliVue Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: May 13, 2015 after 93 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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 (2016), 31 descendants of its own
- K171801: IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable (2017), 8 descendants of its own
- K221704: HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) (2022), 6 descendants of its own
- K210906: IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 (2021), 6 descendants of its own
- K181314: IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension (2018), 6 descendants of its own

## Recalls of this device
- Oct 31, 2025 · Class II · Z-0849-2026: Potential issue where the IntelliVue monitors did not alarm.
- Oct 31, 2025 · Class II · Z-0850-2026: Potential issue where the IntelliVue monitors did not alarm.
- Oct 31, 2025 · Class II · Z-0867-2026: Potential issue where the IntelliVue monitors did not alarm.
- Oct 31, 2025 · Class II · Z-0869-2026: Potential issue where the IntelliVue monitors did not alarm.
- Oct 31, 2025 · Class II · Z-0866-2026: Potential issue where the IntelliVue monitors did not alarm.
- Oct 31, 2025 · Class II · Z-0859-2026: Potential issue where the IntelliVue monitors did not alarm.
- Jun 30, 2020 · Class II · Z-2696-2020: Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not
- Jun 30, 2020 · Class II · Z-2697-2020: Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not
- Aug 23, 2017 · Class II · Z-0292-2018: Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors
- Jan 4, 2016 · Class II · Z-0854-2016: The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor
- Jan 4, 2016 · Class II · Z-0853-2016: The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor

Source page: https://510kreport.com/device/K150310
Methodology: https://510kreport.com/methodology