# K200859: Infinity M300

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Aug 28, 2020 after 149 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (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.
2 later devices descend from it; 1 cites it directly.
0 of 45 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
- K231477: Infinity CentralStation Wide, Infinity M300, Infinity M300+ (2023), 1 descendant of its own
- K240312: Infinity CentralStation Wide (2024), 0 descendants of its own

## Recalls of this device
- Apr 5, 2023 · Class II · Z-1472-2023: 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 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 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 is not compatible for use in an MRI magnetic field.

Source page: https://510kreport.com/device/K200859
Methodology: https://510kreport.com/methodology