ClearanceBrief
510(k) K130849 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450

ApplicantPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN, Boeblingen, Baden-Wuerttemberg, DE
DecisionSubstantially Equivalent, Jun 14, 2013
ReceivedMar 26, 2013
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K130849

DateFirm and productCodeLinked 510(k)
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX400. Product Number: 866060.
Open, Classified		 DSINone listed
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX450. Product Number: 866062.
Open, Classified		 DSINone listed
Oct 4, 2024Philips North America Llc
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3)
Open, Classified		 MHXNone listed
Sep 25, 2024Philips North America
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Open, Classified		 MHXNone listed
Aug 5, 2024Philips North America Llc
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to gene
Open, Classified		 MHXNone listed
Aug 5, 2024Philips North America Llc
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to gen
Open, Classified		 MHXNone listed
Aug 5, 2024Philips North America Llc
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to gene
Open, Classified		 MHXNone listed
Aug 5, 2024Philips North America Llc
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to gene
Open, Classified		 MHXNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.