# K093632: Infinity Acute Care System Workstation Neonatal Care

- Pathway: 510(k) (Traditional)
- Applicant: Drager Medical AG & Co. Kgaa
- Decided: Apr 5, 2010 after 133 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
Longest line of descent: 8 generations back to K902859 (1991). 31 ancestors in all.
10 later devices descend from it; 2 cite it directly.
9 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903089: Babylog 8000 Infant Ventilator, Drager, Inc. (1991) Summary page 2.
- K926292: Babylog 8000 Infant Ventilator, Drager, Inc. (1994) Summary page 2.
- K974176: Babylog 8000 Plus, Drager, Inc. (1998) Summary page 2.
- K961687: EVITA 4, Drager, Inc. (1996) Summary page 2.
- K983219: Neoflow Option Model Numbers 8413563, 8411900, Drager, Inc. (1998) Summary page 2.
- K980642: EVITA 4 (8411900), Drager, Inc. (1998) Summary page 2.
- K992608: Atc Option for Evita 2 Dura and Evita 4, Drager, Inc. (1999) Summary page 2.
- K010093: Non-Invasive Ventilation Niv Option, Model 84 14 474, Drager Medizintechnik GmbH (2001)
- K051263: Evitaxl with Option Smartcare, Drager Medical AG & Co. Kgaa (2005). Our reading of the summary gave K011263, which is not a number in FDA’s lists. Corrected to the only number one digit away that is an earlier device of this one’s maker, Drager Medical AG & Co. Kgaa, in this field.
- K072412: Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models 8415941, 8415942, 6871500, Drager Medical AG & Co. Kgaa (2008) Summary page 2.

## Most influential descendants
- K121225: Hamilton-C2 (2012), 8 descendants of its own
- K123637: Hamilton-C3 (2012), 4 descendants of its own
- K161450: Hamilton-C3 (2017), 3 descendants of its own
- K140939: Hamilton-T1,Hamilton-C1 (2015), 2 descendants of its own
- K201658: Hamilton-C6 (2020), 1 descendant of its own

## Recalls of this device
- Feb 14, 2022 · Class II · Z-0871-2022: Cybersecurity Improvement Action-not equipped against potential cyber security threats
- Sep 10, 2021 · Class II · Z-0109-2022: 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 Neonatal 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 specific therapy in neonatal intensive care. The Infinity Acute Care System Workstations Neonatal 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 waveformis, 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 Babylog VN500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (I I lbs) up to 20 kg (44 Ibs) bodyweight. lBabylog VN500 offers mandatory ventilation modes for spontaneous breathing support and airway monitoring. The Babylog VN500 ventilation unit is used with Infinity C Series Dralger Medical Cockpits. The Babylog VN500 ventilation unit is intended for use in different medical care areas. Babylog VN500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

Source page: https://510kreport.com/device/K093632
Methodology: https://510kreport.com/methodology