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Evitaxl With Option SmartCare

by Drager Medical AG & Co. Kgaa

510(k) K051263

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051263 Date12 Jul 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2327-2008 FDA Unclassified (pre-2012) initiated 2 Jul 2008

    audible power failure alarm was not enunciated at the required volume

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Evitaxl With Option SmartCare is a continuous, facility-use ventilator designed for mechanical ventilation of patients. It provides controlled or assisted ventilation, including pressure-support and volume-control modes, to support respiratory function in intubated or tracheotomized patients.

This device is intended for use in hospital settings and is supplied as a reusable medical system. The SmartCare option is configured for hemodynamically stable patients weighing at least 15 kg with adequate spontaneous breathing. It includes a capnography package with a CO₂ sensor for monitoring expired carbon dioxide. The device is regulated under FDA 510(k) clearance (K051263) and falls under regulation number 868.5895.

Other devices from Drager Medical AG & Co. Kgaa

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of patients is the Evitaxl With Option SmartCare designed to support, and what specific features make it suitable for them?

    The Evitaxl With Option SmartCare is designed for hemodynamically stable patients who weigh at least 15 kg and have adequate spontaneous breathing. The SmartCare option is tailored for these patients by providing automated adjustments to ventilation settings, ensuring optimized respiratory support. This feature is particularly useful in hospital settings where patients require assisted or controlled ventilation, such as those who are intubated or tracheotomized.

  • Is the Evitaxl With Option SmartCare a single-use or reusable device, and how does this affect its maintenance?

    The Evitaxl With Option SmartCare is a reusable medical system, meaning it is intended for use across multiple patients in a facility setting. As a reusable device, it requires proper cleaning, disinfection, and maintenance procedures to ensure safety and functionality between uses. This also means it should be handled and stored according to manufacturer guidelines to prevent contamination and maintain performance.

  • Does the Evitaxl With Option SmartCare include any additional monitoring capabilities, and if so, what are they?

    Yes, the Evitaxl With Option SmartCare includes a capnography package with a CO₂ sensor. This feature allows for real-time monitoring of expired carbon dioxide levels, which is useful for assessing ventilation effectiveness, detecting issues like endotracheal tube placement, and ensuring patient safety during mechanical ventilation.

  • What ventilation modes does the Evitaxl With Option SmartCare support, and how might these modes benefit patients?

    The Evitaxl With Option SmartCare supports both controlled and assisted ventilation modes, including pressure-support and volume-control modes. Pressure-support ventilation helps patients breathe more easily by reducing the effort required, while volume-control ventilation ensures a consistent tidal volume is delivered, which is critical for maintaining adequate oxygenation and ventilation in intubated or tracheotomized patients.

  • How is the regulatory status of the Evitaxl With Option SmartCare determined, and what does this mean for its use in clinical settings?

    The Evitaxl With Option SmartCare is regulated under FDA 510(k) clearance with the classification number K051263, indicating it has been deemed substantially equivalent to a legally marketed device. This means it has undergone review by the FDA to ensure it meets safety and effectiveness standards for use in hospital settings as a facility-use ventilator. Clinicians can rely on this clearance to confirm the device’s compliance with regulatory requirements for mechanical ventilation.