# K113798: Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Mar 22, 2012 after 90 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K941811 (1994). 166 ancestors in all.
23 later devices descend from it; 4 cite it directly.
1 of 190 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093788: Infinity Acute Care System (Iacs) Monitoring Solution, Draeger Medical Systems, Inc. (2010) Summary page 1.
- K061329: Infinity Masimo Set SP02 Pod, Draeger Medical Systems, Inc. (2006) Summary page 1.
- K110028: Masimo Radical Y Pulse CO-Oximeter, Masimo Corporation (2011) Summary page 1.

## 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
- 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.
- Mar 28, 2018 · Class II · Z-1813-2018: Software anomaly resulting in the loss of patient settings and stored patient data.
- Feb 21, 2018 · Class II · Z-1382-2018: The invasive pressure visual and audible alarms may not activate.
- Oct 4, 2017 · Class II · Z-0942-2018: Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potential
- Jun 6, 2017 · Class II · Z-2734-2017: Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.
- Dec 10, 2013 · Class II · Z-0714-2014: After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 va
- 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

## Indications for use
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. 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 professional. 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 (only available when the M540 is docked in an IACS configuration) - Arterial oxygen saturation (SpO₂) - Pulse rate - Perfusion Index (PI) - Total hemoglobin (SpHb) (adult and pediatric only) - Total oxygen content (SpCO) (adult and pediatric only) - Methemoglobin saturation (SpMet) - Pleth variability index (PVI) - Mainstream etCO₂

Source page: https://510kreport.com/device/K113798
Methodology: https://510kreport.com/methodology