510(k) Report

FDA applicant

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

Boeblingen, Baden-Wuerttemberg, DE25 decisions2007–201432 recalls

FDA records 25 decisions for Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE) from 2007 to 2014: 25 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and DSI (Detector And Alarm, Arrhythmia). Its devices cite 415 predicates, 115 of them its own earlier devices. 32 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Philips Medizinsysteme Boeblingen GmbH, Cardiac AN’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2007: 42008: 12009: 52010: 42011: 42012: 22013: 32014: 2
2007high 5 (2009) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

10in 2025

2008: 12009: 42010: 42012: 12014: 32016: 12020: 22023: 12024: 52025: 10
2007high 10 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Philips Medizinsysteme Boeblingen GmbH, Cardiac AN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)15decisions
  • DSIDetector And Alarm, Arrhythmia3decisions
  • HGMSystem, Monitoring, Perinatal2decisions
  • DQAOximeter2decisions
  • BZQMonitor, Breathing Frequency1decision
  • LKDMonitor, Carbon-Dioxide, Cutaneous1decision

Also: DXJ (1).

Whose devices does it build on?

Its devices cite 415 predicates; 115 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 215 times; 115 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 200723cite it
  • K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 200820cite it
  • K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 200719cite it
  • K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 200918cite it
  • K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 201017cite it
  • K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 201114cite it

What has FDA decided for it lately?

  • K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20141 recall
  • K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014
  • K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20135 recalls
  • K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013
  • K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20138 recalls
  • K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012
  • K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20121 recall
  • K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011

All 25 as Philips Medizinsysteme Boeblingen GmbH, Cardiac AN →

What has been recalled?

32 recalls linked to its devices; the latest:

  • K131872IntelliVue Patient Monitor MX550. Product Number: 866066.Oct 31, 2025Class II
  • K130849IntelliVue Patient Monitor MX400. Product Number: 866060.Oct 31, 2025Class II
  • K131872IntelliVue Patient Monitor MX500. Product Number: 866064.Oct 31, 2025Class II
  • K130849IntelliVue Patient Monitor MX450. Product Number: 866062.Oct 31, 2025Class II
  • K181467Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub…Apr 7, 2025Class II
  • K082583IntelliBridge EC10 Module. Model Number: 865115Jan 15, 2025Class II