# K161767: Philips IntelliVue GuardianSoftware

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Jan 27, 2017 after 214 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: 34 generations back to K941811 (1994). 266 ancestors in all.
23 later devices descend from it; 2 cite it directly.
2 of 290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151736: Philips IntelliVue GuardianSoftware, Philips Medizin Systeme Boblingen GmbH (2015) Summary page 5.

## Most influential descendants
- K182543: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package (2018), 19 descendants of its own
- K190073: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub (2019), 18 descendants of its own
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own
- K210133: Current Health Monitoring System Gen 2 (G2) (2021), 8 descendants of its own
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own

## Indications for use
The IntelliVue GuardianSoftware is indicated for use by healthcare providers whenever there is a need for generation of a patient record. The IntelliVue GuardianSoftware is intended for use in the collection, storage and management of data from Philips specified measurements and Philips Patient Monitors that are connected through networks.

Source page: https://510kreport.com/device/K161767
Methodology: https://510kreport.com/methodology