# K260579: Infinity® Acute Care System (IACS) – VG8.1

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Aug 20, 2026 after 181 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K941811 (1994). 169 ancestors in all.
No later device cites it as a predicate yet.
1 of 170 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203088: Infinity Acute Care System (IACS) Monitoring System, Draeger Medical Systems, Inc. (2022) Summary page 7.

## 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) - 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) - Non-invasive arterial oxygen saturation (SpO2) including: o Pulse rate o Perfusion index (PI) o Total hemoglobin (SpHb) (adult and pediatric patients only) o Total oxygen content (SpOC) (adult and pediatric patients only) o Carboxyhemoglobin saturation (SpCO) (adult and pediatric patients only) o Methemoglobin saturation (SpMet) o Pleth variability index (PVI) The IACS is also capable of connecting to third-party devices to display physiologic, multi-parameter data, store trends, and send data across a network. 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. 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) - 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) - Non-invasive arterial oxygen saturation (SpO2) including: o Pulse rate o Perfusion index (PI) o Total hemoglobin (SpHb) (adult and pediatric patients only) o Total oxygen content (SpOC) (adult and pediatric patients only) o Carboxyhemoglobin saturation (SpCO) (adult and pediatric patients only) o Methemoglobin saturation (SpMet) o Pleth variability index (PVI)

Source page: https://510kreport.com/device/K260579
Methodology: https://510kreport.com/methodology