# K240312: Infinity CentralStation Wide

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Aug 1, 2024 after 181 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: 31 generations back to K941811 (1994). 215 ancestors in all.
No later device cites it as a predicate yet.
0 of 216 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231477: Infinity CentralStation Wide, Infinity M300, Infinity M300+, Draeger Medical Systems, Inc. (2023) Summary page 4.

## Indications for use
The Infinity CentralStation (ICS) is intended for use by trained health care professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation. Infinity CentralStation with Rest ECG is intended for the production and interpretation of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.

Source page: https://510kreport.com/device/K240312
Methodology: https://510kreport.com/methodology