# K151860: Infinity CentralStation Wide

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Sep 2, 2015 after 56 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K923682 (1992). 42 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130711: Infinity Centralstation with Infinity M300, Draeger Medical Systems, Inc. (2013) Summary page 4.

## Most influential descendants
- K182543: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package (2018), 19 descendants of its own
- K190073: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub (2019), 18 descendants of its own
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own
- K210133: Current Health Monitoring System Gen 2 (G2) (2021), 8 descendants of its own
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own

## Recalls of this device
- Jan 14, 2025 · Class II · Z-1066-2025: Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
- Apr 5, 2023 · Class II · Z-1471-2023: The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with

## 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.

Source page: https://510kreport.com/device/K151860
Methodology: https://510kreport.com/methodology