# K072412: Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models 8415941, 8415942, 6871500

- Pathway: 510(k) (Traditional)
- Applicant: Drager Medical AG & Co. Kgaa
- Decided: Feb 6, 2008 after 163 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K902859 (1991). 27 ancestors in all.
23 later devices descend from it; 3 cite it directly.
14 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051263: Evitaxl with Option Smartcare, Drager Medical AG & Co. Kgaa (2005) Summary page 1.

## Most influential descendants
- K103803: Hamilton-G5 (2011), 14 descendants of its own
- K102775: Hamilton-C2 (2011), 14 descendants of its own
- K112006: Hamilton-TC1 (2012), 13 descendants of its own
- K120670: Hamilton-T1 (2012), 11 descendants of its own
- K131774: Hamilton-G5 (2013), 10 descendants of its own

## 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 SmartCareTM/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 haemodynamically 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. SmartCareTM/PS is contraindicated in case of severe COPD and severe neurologic disorder that affects the cerebral control mechanism of the spontaneous breathing pattern.

Source page: https://510kreport.com/device/K072412
Methodology: https://510kreport.com/methodology