510(k) Report

FDA applicant

Philips Medizin Systeme Boeblingen GmbH

Boeblingen, DE48 decisions2004–202637 recalls

FDA records 48 decisions for Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE) from 2004 to 2026: 48 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and HGM (System, Monitoring, Perinatal). Since 2016 its 510(k)s took a median of 194 days from receipt to decision, against 196 for FDA’s reviews in the same codes and years. Its devices cite 349 predicates, 122 of them its own earlier devices. 37 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 Medizin Systeme Boeblingen GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008: 32010: 22012: 12013: 22015: 32016: 12017: 32018: 42019: 32020: 12021: 22023: 32024: 12025: 12026 (partial year): 1
2007high 4 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

18in 2025

2009: 22010: 22014: 12016: 32017: 42020: 32023: 42025: 18
2007high 18 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Philips Medizin Systeme Boeblingen GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)25decisions
  • HGMSystem, Monitoring, Perinatal7decisions
  • DXJDisplay, Cathode-Ray Tube, Medical3decisions
  • DQAOximeter3decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • DSIDetector And Alarm, Arrhythmia2decisions

Also: DSJ (1), CBQ (1), MSX (1), CCK (1), BZQ (1), DRG (1).

How long do its 510(k) reviews take?

Since 2016, its 17 510(k)s took a median of 194 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 196 days; 8 of its 17 were faster than that.

Whose devices does it build on?

Its devices cite 349 predicates; 122 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 347 times; 122 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.

  • K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 200432cite it
  • K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 200531cite it
  • K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 200429cite it
  • K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH · 200625cite it
  • K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 200525cite it
  • K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 200625cite it

What has FDA decided for it lately?

  • K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX…Philips Medizin Systeme Boeblingen GmbH · 2026
  • K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH · 2025
  • K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)Philips Medizin Systeme Boeblingen GmbH · 2024
  • K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH · 2023
  • K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH · 2023
  • K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH · 2023
  • K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4Philips Medizin Systeme Boeblingen GmbH · 20212 recalls
  • K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH · 2021

All 48 as Philips Medizin Systeme Boeblingen GmbH →

What has been recalled?

37 recalls linked to its devices; the latest:

  • K150310IntelliVue MP2. Product Number: M8102A.Oct 31, 2025Class II
  • K150310IntelliVue MP5. Product Number: M8105A.Oct 31, 2025Class II
  • K122439IntelliVue MP30. Product Number: M8002A.Oct 31, 2025Class II
  • K151681IntelliVue MP70. Product Number: M8007A.Oct 31, 2025Class II
  • K150310IntelliVue Patient Monitor MX700. Product Number: 865241.Oct 31, 2025Class II
  • K151681IntelliVue MP50. Product Number: M8004A.Oct 31, 2025Class II