# K203088: Infinity Acute Care System (IACS) Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Feb 1, 2022 after 476 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: 16 generations back to K941811 (1994). 168 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 170 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201764: Infinity Acute Care System (IACS) Monitoring Solution, Draeger Medical Systems, Inc. (2021). Cleared while this submission was under review Summary page 7.
- K113798: Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set, Draeger Medical Systems, Inc. (2012) Summary page 7.

## Most influential descendants
- K260579: Infinity® Acute Care System (IACS) – VG8.1 (2026), 0 descendants of its own

## Recalls of this device
- May 13, 2024 · Class II · Z-2189-2024: Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical

## Indications for use
Intended Use Infinity® Acute Care System™ (IACS) 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 health care professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network. The IACS and optional connected hardware are not intended for use in the following hospital environments: — Hyperbaric chambers — Environments containing MRI equipment Indications for use The IACS, in connection with the M540 Patient Monitor, monitors the following parameters: — Heart rate — Arrhythmia (adult and pediatric patients only) — 12-lead Rest ECG analysis (adult and pediatric patients only) — ST segment analysis including TruST (adult and pediatric patients only) — Apnea — Impedance respiratory rate — RRi — Invasive blood pressure — IBP — Non-invasive blood pressure — NIBP — Temperature — Cardiac output (adult and pediatric patients only) — Carbon dioxide — etCO2, inCO2, RRc — Arterial oxygen saturation — SpO2 — Pulse rate — Perfusion index — PI — Total hemoglobin — SpHb, (adult and pediatric patients only) — Total oxygen content — SpOC, (adult and pediatric patients only) — Carboxyhemoglobin saturation — SpCO (adult and pediatric patients only) — Methemoglobin saturation — SpMet — Pleth variability index — PVI The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network. Intended Use The Infinity Medical Cockpits, consisting of the C500, and the C700 are monitoring and control displays for the Infinity Acute Care System (IACS). Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings. The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals. Indications for Use As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use. Intended Use The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient information in environments where patient care is provided by trained health care professionals. The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multi-parameter data collected from the M540 is made available on the Infinity network. The M540 is intended to monitor one patient at a time. The M540 and any connected hardware are not intended for use in the following hospital environments: — Hyperbaric chambers — Environments containing MRI equipment Indications for use The M540 monitors the following parameters: — Heart rate — Arrhythmia (adult and pediatric patients only) — 12-lead Rest ECG analysis (adult and pediatric patients only) — ST segment analysis including TruST (adult and pediatric patients only) — Apnea — Impedance respiratory rate — RRi — Invasive blood pressure — IBP — Non-invasive blood pressure — NIBP — Temperature — Cardiac output — only available when the M540 is docked in an IACS configuration (adult and pediatric patients only) — Carbon dioxide — etCO2, inCO2, RRc — Arterial oxygen saturation — SpO2 — Pulse rate — Perfusion index — PI — Total hemoglobin — SpHb, (adult and pediatric patients only) — Total oxygen content — SpOC, (adult and pediatric patients only) — Carboxyhemoglobin saturation — SpCO (adult and pediatric patients only) — Methemoglobin saturation — SpMet — Pleth variability index — PVI

Source page: https://510kreport.com/device/K203088
Methodology: https://510kreport.com/methodology