# K100272: Intellivue Clinical Information Portfolio

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Apr 14, 2010 after 75 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941811 (1994). 15 ancestors in all.
46 later devices descend from it; 5 cite it directly.
0 of 62 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 5.

## Most influential descendants
- K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own
- 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

## Recalls of this device
- Jul 8, 2011 · Not classified · Z-3111-2011: Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventions or additional medi
- Mar 16, 2011 · Not classified · Z-2175-2011: Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.

## Indications for use
Intended for use in the data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. This device is indicated for use by health care providers whenever there is a need for generation of a patient record and computatioh of drug dosage.

Source page: https://510kreport.com/device/K100272
Methodology: https://510kreport.com/methodology