# K093633: Infinity Acute Care System Workstation Critical Care

- Pathway: 510(k) (Traditional)
- Applicant: Draegerwerk AG & CO Kgaa
- Decided: Mar 30, 2010 after 127 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 6 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 5 cite it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K181695: Nihon Kohden NKV-550 Series Ventilator System (2018), 4 descendants of its own
- K192307: Nihon Kohden NKV-550 Series Ventilator System (2020), 3 descendants of its own
- K133886: Perseus A500 (2014), 2 descendants of its own
- K230931: Atlan (2023), 1 descendant of its own
- K222644: Nihon Kohden NKV-440 Ventilator System (2023), 1 descendant of its own

## Recalls of this device
- Feb 14, 2022 · Class II · Z-0870-2022: Cybersecurity Improvement Action-not equipped against potential cyber security threats
- Sep 10, 2021 · Class II · Z-0108-2022: Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
- Feb 4, 2016 · Class I · Z-0827-2016: The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power sup
- Dec 1, 2015 · Class I · Z-0436-2016: The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to
- Jul 13, 2015 · Class I · Z-2343-2015: The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
- Feb 7, 2014 · Class I · Z-1298-2014: The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.

## Indications for use
The Infinity Acute Care System Workstations Critical Care consist of monitoring and control displays and additional therapy units. They are intended to be used as integrated, networked, and configurable workstations to provide critical care specific therapy. The Infinity Acute Care System Workstations Critical Care are intended to be used by qualified and trained medical personnel. The Infinity C Series 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. The Evita V500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of adult, pediatric and neonatal patients. Evita V500 offers mandatory ventilation modes and ventilation modes for spontaneous breathing support and airway monitoring. The Evita V500 ventilation unit is used with Infinity C Series Dr~ger Medical Cockpits. The Evita V500 ventilation unit is intended for use in different medical care areas. Evita V500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

Source page: https://510kreport.com/device/K093633
Methodology: https://510kreport.com/methodology