# Philips Medizin Systeme Boblingen GmbH

- Location (FDA's records): Boeblingen, DE
- FDA decisions: 22 (2001–2026): 22 510(k) clearances
- Names in FDA's records: Philips Medizin Systeme Boblingen GmbH (12); Philips Medizin Systeme Böblingen GmbH (10)
- Product codes: MHX (11), HGM (2), MSX (2), DQA (2), DSA (1), DSI (1), MLO (1), DXJ (1), DPS (1)
- 510(k) review time since 2016: median 200 days, against 192 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 120 (13 its own); citations of its devices by later devices: 137 (13 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medizin Systeme Boeblingen GmbH: 38 (https://510kreport.com/company/philips-medizin-systeme-boeblingen)
- Philips Medical Systems, Inc.: 27 (https://510kreport.com/company/philips-medical-systems)
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN: 21 (https://510kreport.com/company/philips-medizinsysteme-boeblingen-cardiac-an)
- Philips Medical Systems North America, Inc.: 4 (https://510kreport.com/company/philips-medical-systems-north-america)
- Agilent Technologies Deutschland GmbH: 3 (https://510kreport.com/company/agilent-technologies-deutschland)
- Hewlett-Packard Co.: 3 (https://510kreport.com/company/hewlett-packard)
- Agilent Technologies, Inc.: 3 (https://510kreport.com/company/agilent-technologies)
- Edwards Lifesciences, LLC: 1 (https://510kreport.com/company/edwards-lifesciences)

## Firms that cite its devices most
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN: 57 (https://510kreport.com/company/philips-medizinsysteme-boeblingen-cardiac-an)
- Philips Medizin Systeme Boeblingen GmbH: 47 (https://510kreport.com/company/philips-medizin-systeme-boeblingen)
- Philips Medical Systems North America, Inc.: 6 (https://510kreport.com/company/philips-medical-systems-north-america)
- Philips Medical Systems, Inc.: 5 (https://510kreport.com/company/philips-medical-systems)
- Mindray North America: 1 (https://510kreport.com/company/mindray-north-america)
- Visicu, Inc.: 1 (https://510kreport.com/company/visicu)
- Respiratory Motion, Inc.: 1 (https://510kreport.com/company/respiratory-motion)
- Dpcom AS: 1 (https://510kreport.com/company/dpcom)

## Its most-cited devices
- K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. (2003), cited by 37
- K042845: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors (2004), cited by 29
- K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors (2006), cited by 21
- K102562: Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 (2010), cited by 18
- K113657: Intellivue Patient Monitor (2012), cited by 10
- K031481: The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 (2003), cited by 9

## Recent decisions
- K252821: Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) (May 29, 2026)
- K253654: IntelliVue Measurement Rack 6000 (867317) (Mar 30, 2026)
- K251702: IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) (Nov 10, 2025)
- K250453: IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) (Sep 2, 2025)
- K242962: Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)
- K241890: Philips Holter Analysis System (Mar 21, 2025)
- K243545: Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC;  989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC;  M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m;  M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m;  M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m;  M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m;  M1663A,10 Lead ECG Trunk AAMI/IEC 2m;  M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m;  M1671A, 3 Leadset, Grabber, AAMI, ICU;  M1673A, 3 Leadset, Sn (Jan 17, 2025)
- K241556: Cardiac Workstation (5000); Cardiac Workstation (7000) (Dec 17, 2024)

Source page: https://510kreport.com/company/philips-medizin-systeme-boblingen