# K093788: Infinity Acute Care System (Iacs) Monitoring Solution

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Mar 8, 2010 after 89 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K923682 (1992). 60 ancestors in all.
24 later devices descend from it; 1 cites it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051658: Infinity Alpha, Draeger Medical Systems, Inc. (2005) Summary page 3.
- K070566: Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL, Draeger Medical Systems, Inc. (2007) Summary page 3.
- K060254: Modification to Infinity Explorer, Draeger Medical Systems, Inc. (2006) Summary page 3.

## Most influential descendants
- K113798: Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set (2012), 23 descendants of its own
- 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

## Recalls of this device
- Dec 23, 2020 · Class II · Z-1104-2021: The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to 
- Sep 13, 2019 · Class II · Z-0258-2020: Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
- Dec 13, 2012 · Class II · Z-0939-2013: The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This
- Oct 18, 2011 · Not classified · Z-0263-2012: During product training on the Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) it was discovered that the weight-based drug dosage calculation may indicate incorrect recommended values

## Indications for use
The Infinity® Acute Care System™ (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained healthcare professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. Intended Use: Infinity M540 Patient Monitor The Infinity M540 is intended for the monitoring of multi-parameter, physiological patient information obtained from connected hardware in environments where patient care is provided by trained healthcare professionals. The M540 is intended to monitor one patient at a time. The M540 monitors the following parameters: - heart rate - Arrhythmia (adult and pediatric only) - 12-lead analysis - ST segment analysis including TruST® (adult and pediatric only) - 12-lead ST segment analysis (adult and pediatric only) - Apnea - Respiration rate - Invasive pressure - Non-invasive pressure - Temperature - Cardiac output - Arterial oxygen saturation - Pulse rate (SpO2) - Mainstream etCO2 MRI Compatibility Statement: The IACS, Infinity M540 and any connected optional hardware are not intended for use in hyperbaric chambers and environments containing MRI equipment

Source page: https://510kreport.com/device/K093788
Methodology: https://510kreport.com/methodology