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

Philips Medizin Systeme Böblingen GmbH · Predicate Candidate Screening

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

130 daysmedian FDA review time
266 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable AdulPhilips Medizin Systeme Böblingen GmbH2026-05-292670
K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH2026-03-301300
K251702IntelliVue Patient Monitor MX750; IntelliVue Patient MonitorPhilips Medizin Systeme Böblingen GmbH2025-11-101610
K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient MPhilips Medizin Systeme Böblingen GmbH2025-09-021960
K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH2025-05-052221
K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbH2025-03-212660
K243545Philips Reusable ECG Lead Sets and Trunk Cables : Model NumbPhilips Medizin Systeme Böblingen GmbH2025-01-17630
K241556Cardiac Workstation (5000); Cardiac Workstation (7000)Philips Medizin Systeme Böblingen GmbH2024-12-172004
K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue PatientPhilips Medizin Systeme Böblingen GmbH2023-02-032700
K211900Patient Information Center iXPhilips Medizin Systeme Böblingen GmbH2022-03-042560
K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH2015-10-211170
K140535PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 ANPhilips Medizin Systeme Boblingen GmbH2014-11-252663
K113657INTELLIVUE PATIENT MONITORPhilips Medizin Systeme Boblingen GmbH2012-03-221010
K102958PHILIPS AVALON FETAL MONITORPhilips Medizin Systeme Boblingen GmbH2011-03-181650
K102562INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20,Philips Medizin Systeme Boblingen GmbH2010-10-21440
K090360PHILIPS M3001A MULTI MEASUREMENT SERVERPhilips Medizin Systeme Boblingen GmbH2009-05-04810
K083228PHILIPS INTELLIVUE MP5 PATIENT MONITORPhilips Medizin Systeme Boblingen GmbH2008-11-24210
K060541THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTEPhilips Medizin Systeme Boblingen GmbH2006-03-24232
K042845THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTPhilips Medizin Systeme Boblingen GmbH2004-11-12280
K032858THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIEPhilips Medizin Systeme Boblingen GmbH2003-10-10280
K031481THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORSPhilips Medizin Systeme Boblingen GmbH2003-05-29170
K013624MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), VPhilips Medizin Systeme Boblingen GmbH2001-12-03280

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