# K051263: Evitaxl with Option Smartcare

- Pathway: 510(k) (Traditional)
- Applicant: Drager Medical AG & Co. Kgaa
- Decided: Jul 12, 2005 after 57 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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: 6 generations back to K902859 (1991). 26 ancestors in all.
51 later devices descend from it; 9 cite it directly.
22 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980642: EVITA 4 (8411900), Drager, Inc. (1998) Summary page 2.
- K983219: Neoflow Option Model Numbers 8413563, 8411900, Drager, Inc. (1998) Summary page 2.
- K992608: Atc Option for Evita 2 Dura and Evita 4, Drager, Inc. (1999) Summary page 3.
- K010093: Non-Invasive Ventilation Niv Option, Model 84 14 474, Drager Medizintechnik GmbH (2001) Summary page 2.
- K040574: Galileo Gold, Hamilton Medical, Inc. (2004) Summary page 3.
- K970839: Servo Ventilator 300A, Siemens Elema AB (1997) Summary page 3.
- K021573: Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option, Puritan-Bennett (2002) Summary page 3.

## Most influential descendants
- K061090: Galileo Gold Asv (2006), 36 descendants of its own
- K070513: Hamilton-G5 (2007), 26 descendants of its own
- K072412: Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models 8415941, 8415942, 6871500 (2008), 23 descendants of its own
- K080181: Modification to Galileo Gold (2008), 21 descendants of its own
- K081521: Modification to Hamilton-G5 (2008), 16 descendants of its own

## Recalls of this device
- Jul 2, 2008 · Not classified · Z-2327-2008: audible power failure alarm was not enunciated at the required volume

## Indications for use
The EvitaXL is a long-term ventilator for intensive care for adults, children, and infants with a body weight of at least 3 kg (6.6 lbs). With SmartCare"/PS the EvitaXL is intended to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support for adults and children with a body weight of at least 15 kg (33 lbs). The patients should be haemodynamicaily stable with adequate oxygenation and spontaneous breathing. SmartCare can be used for intubated or tracheotomized patients. Patients with body weight between 15 and 35 kg (33.1 and 77.8 lbs) must be endotracheally intubated and ventilated with active humidification. SmartCarew/PS is contraindicated in case of severe COPD and severe neurologic disorder that effects the cerebral control mechanism of the spontaneous breathing pattern.

Source page: https://510kreport.com/device/K051263
Methodology: https://510kreport.com/methodology