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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Predicate Candidate Screening

25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

84 daysmedian FDA review time
204 days90th percentile
25clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K141015INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2014-05-19280
K132320INTELLIVUE CL RESPIRATION PODPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2014-03-262440
K131872INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2013-10-171154
K131829INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2013-08-16570
K130849INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2013-06-14808
K120366INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012-07-181630
K113441PHYSIOLOGICAL MONITOR, PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012-03-221221
K111905INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP0Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011-10-04910
K110474PHILIPS INTELLIVUE TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011-09-302241
K111083PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011-08-171201
K110622INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011-03-31282
K101600INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2010-08-31840
K101449INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2010-06-18250
K093268INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2010-05-112042
K100939INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010-04-30250
K091927INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009-11-031260
K091572DISPOSABLE SPO2 SENSOR M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2009-09-221120
K091395MP5 INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2009-06-05250
K082583INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP4Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009-02-251705
K083517INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP4Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009-01-16511
K082633INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5,Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2008-10-03232
K071800PHILIPS AVALON FETAL MONITORS FM20 AND FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007-09-27874
K072070PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORSPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007-08-10110
K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007-06-13210
K063725MP5 INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007-02-08550

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda