# K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decided: Oct 4, 2011 after 91 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 31 generations back to K941811 (1994). 244 ancestors in all.
36 later devices descend from it; 2 cite it directly.
2 of 281 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992636: HP Carevue 9000 Clinical Information System, Model M2331A, Hewlett-Packard Co. (1999) Summary page 2.
- K100272: Intellivue Clinical Information Portfolio, Philips Medical Systems (2010) Summary page 2.
- K082633: Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2008) Summary page 2.
- K083517: Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) Summary page 2.
- K091927: Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) Summary page 2.
- K093268: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 2.
- K100939: Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 2.
- K101419: Ensite Velocity System, Model EE3000, St Jude Medical (2010)
- K102562: Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800, Philips Medizin Systeme Boblingen GmbH (2010) Summary page 2.
- K110622: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2011) Summary page 2.
- K101600: Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 2.

## Most influential descendants
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own
- K151736: Philips IntelliVue GuardianSoftware (2015), 24 descendants of its own
- K161767: Philips IntelliVue GuardianSoftware (2017), 23 descendants of its own
- K132320: Intellivue CL Respiration Pod (2014), 20 descendants of its own
- K182543: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package (2018), 19 descendants of its own

## Indications for use
The IntelliVue Guardian Software is indicated for use by healthcare providers whenever there is a need for generation of a patient record. The IntelliVue Guardian Software is intended for use in the collection, storage and management of data from IntelliVue Cableless Measurements and IntelliVue Patient Monitors that are connected through networks. The IntelliVue CL SpO2 Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters SpO2 and pulse rate wirelessly. The intended use of the IntelliVue CL SpO2 Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, recording, and alarming of arterial oxygen saturation and pulse rate of adult and pediatric patients. The IntelliVue CL SpO2 Pod is also intended for acquisition of arterial oxygen saturation and pulse rate data of adult and pediatric patients for a clinical information management system. The IntelliVue CL SpO2 Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device. The IntelliVue CL NBP Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters non-invasive blood pressure and pulse rate wirelessly. The intended use of the IntelliVue CL NBP Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, recording, and alarming of systolic, diastolic, and mean pressure and pulse rate of adult and pediatric patients. The IntelliVue CL NBP Pod is also intended for acquisition of systolic, diastolic, and mean pressure and pulse rate data of adult and pediatric patients for a clinical information management system. The IntelliVue CL NBP Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device.

Source page: https://510kreport.com/device/K111905
Methodology: https://510kreport.com/methodology