Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Philips Medizin Systeme Boeblingen GmbH · Predicate Candidate Screening

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

95 daysmedian FDA review time
261 days90th percentile
48clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Philips Medizin Systeme Boeblingen GmbH2026-02-061620
K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH2025-10-171860
K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL FetPhilips Medizin Systeme Boeblingen GmbH2024-07-022580
K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue PatienPhilips Medizin Systeme Boeblingen GmbH2023-12-191940
K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Philips Medizin Systeme Boeblingen GmbH2023-11-222640
K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue PatienPhilips Medizin Systeme Boeblingen GmbH2023-08-222650
K210906IntelliVue Patient Monitor MX750, IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2021-10-071952
K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH2021-09-30770
K192137IntelliVue Patient Monitor MX500, IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2020-09-114010
K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX50Philips Medizin Systeme Boeblingen GmbH2019-11-193890
K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH2019-10-272303
K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH2019-04-262140
K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH2018-11-151290
K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH2018-09-102580
K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-MeasuremePhilips Medizin Systeme Boeblingen GmbH2018-09-041100
K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH2018-07-161380
K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtPhilips Medizin Systeme Boeblingen GmbH2017-12-26950
K171801IntelliVue Patient Monitor MX100 and Multi-Measurement ModulPhilips Medizin Systeme Boeblingen GmbH2017-10-061124
K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH2017-01-272140
K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and MultiPhilips Medizin Systeme Boeblingen GmbH2016-07-01290
K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015-07-17257
K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips InPhilips Medizin Systeme Boeblingen GmbH2015-06-25730
K150310IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015-05-13936
K131913INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PAPhilips Medizin Systeme Boeblingen GmbH2013-11-261531
K122223NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORPhilips Medizin Systeme Boeblingen GmbH2013-04-122610
K122439INTELLIVUE PATIENT MONITORPhilips Medizin Systeme Boeblingen GmbH2012-08-29193
K100420PHILIPS OBTRACEVUE MODEL SW REV. G.00Philips Medizin Systeme Boeblingen GmbH2010-07-261600
K092028PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50Philips Medizin Systeme Boeblingen GmbH2010-02-172260
K081793PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841Philips Medizin Systeme Boeblingen GmbH2008-10-141110
K081937PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MOPhilips Medizin Systeme Boeblingen GmbH2008-08-29530
K081203OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RPhilips Medizin Systeme Boeblingen GmbH2008-05-28300
K063315INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, Philips Medizin Systeme Boeblingen GmbH2006-11-20180
K062392PHILIPS MP5 INTELLIVUE PATIENT MONITORPhilips Medizin Systeme Boeblingen GmbH2006-09-06210
K062137MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30Philips Medizin Systeme Boeblingen GmbH2006-08-24292
K061610PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MPhilips Medizin Systeme Boeblingen GmbH2006-08-14660
K060221THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MPhilips Medizin Systeme Boeblingen GmbH2006-02-17180
K053522PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATPhilips Medizin Systeme Boeblingen GmbH2006-01-10220
K052795PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30Philips Medizin Systeme Boeblingen GmbH2005-12-30881
K052377PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.Philips Medizin Systeme Boeblingen GmbH2005-11-17790
K052801INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, Philips Medizin Systeme Boeblingen GmbH2005-11-02300
K051366PICONIBP OEM MODULEPhilips Medizin Systeme Boeblingen GmbH2005-09-141120
K051106THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP9Philips Medizin Systeme Boeblingen GmbH2005-07-01600
K050762PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40,Philips Medizin Systeme Boeblingen GmbH2005-04-22290
K050141THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTEPhilips Medizin Systeme Boeblingen GmbH2005-02-11170
K042306PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131APhilips Medizin Systeme Boeblingen GmbH2004-10-15510
K041235PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVPhilips Medizin Systeme Boeblingen GmbH2004-06-04240
K040917PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026BPhilips Medizin Systeme Boeblingen GmbH2004-04-29212
K040304PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004-03-01210

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