# K231477: Infinity CentralStation Wide, Infinity M300, Infinity M300+

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Oct 17, 2023 after 148 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: 30 generations back to K941811 (1994). 214 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 216 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151860: Infinity CentralStation Wide, Draeger Medical Systems, Inc. (2015) Summary page 4.
- K200859: Infinity M300, Draeger Medical Systems, Inc. (2020) Summary page 4.
- K193391: BeneVision Central Monitoring System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K240312: Infinity CentralStation Wide (2024), 0 descendants of its own

## Indications for use
The Infinity CentralStation (ICS) is intended for use by trained healthcare 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. The Infinity M300/M300+ is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network. The Infinity M300/M300+ with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes. Contraindications: The Infinity M300/M300+ is not compatible for use in an MRI magnetic field.

Source page: https://510kreport.com/device/K231477
Methodology: https://510kreport.com/methodology