# K203579: Infinity Gateway Suite

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Jun 7, 2022 after 547 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K900598 (1990). 9 ancestors in all.
1 later device descends 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)
- K043549: Infinity Gateway Suite, VF4, Draeger Medical Systems, Inc. (2005) Summary page 5.

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

## Indications for use
The Infinity Gateway 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/K203579
Methodology: https://510kreport.com/methodology