# K212208: Philips IntelliVue GuardianSoftware (Rev. E.0X)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Sep 30, 2021 after 77 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: 36 generations back to K941811 (1994). 268 ancestors in all.
No later device cites it as a predicate yet.
2 of 269 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180534: Philips IntelliVue GuardianSoftware, Philips Medizin Systeme Boeblingen GmbH (2018) Summary page 4.

## Indications for use
The IntelliVue GuardianSoftware is intended for use by healthcare providers whenever there is a need for generation of a patient record. The IntelliVue GuardianSoftware is indicated for use in the collection, storage and management of data from Philips specified measurements, Philips Patient Monitors and qualified 3rd party measurements that are connected through networks.

Source page: https://510kreport.com/device/K212208
Methodology: https://510kreport.com/methodology