# K043549: Infinity Gateway Suite, VF4

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Jan 21, 2005 after 29 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K900598 (1990). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030657: Siemens Infinity Gateway Suite, Model VF2, Siemens Medical Solutions (2003) Summary page 1.

## Most influential descendants
- K203579: Infinity Gateway Suite (2022), 1 descendant of its own
- K233834: Infinity Gateway Suite (2024), 0 descendants of its own

## Indications for use
The Infinity MultiView WorkStation, Infinity Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger patient monitoring systems and recorders. The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

Source page: https://510kreport.com/device/K043549
Methodology: https://510kreport.com/methodology