# K103646: Intellivue MX40 Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Phillips Medical Systems
- Decided: Jan 7, 2011 after 24 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K941811 (1994). 167 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040357: M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry Monitoring System II, Philips Medical Systems, Inc. (2004) Summary page 1.
- K041741: M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry System II Including M4841A Patien, Philips Medical Systems, Inc. (2004) Summary page 1.
- K081793: Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver, Philips Medizin Systeme Boeblingen GmbH (2008) Summary page 1.
- K062392: Philips MP5 Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 1.
- K063725: MP5 Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) Summary page 1.

## Most influential descendants
- K113125: Intellivue MX40 Patient Monitor (2011), 14 descendants of its own
- K172226: MX40 Release B.07 (2017), 13 descendants of its own
- K193391: BeneVision Central Monitoring System (2020), 10 descendants of its own
- K220058: BeneVision Central Monitoring System (2022), 3 descendants of its own
- K223567: CNS-2101 Central Monitor (2023), 2 descendants of its own

## Recalls of this device
- May 22, 2014 · Class II · Z-1746-2014: IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.

## Indications for use
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Source page: https://510kreport.com/device/K103646
Methodology: https://510kreport.com/methodology