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OPTION SMARTCARE FOR EVITAXL, SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART - 8415942

by Drager Medical AG & Co. Kgaa

510(k) K072412

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK072412 Date6 Feb 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Models / Variants
8415942
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Option SmartCare for EvitaXL is a CO2 sensor CapnoSmart device that is part of a SmartCare Kit Capno Package. It is designed for use with ventilators, specifically the EvitaXL model, to monitor carbon dioxide levels during patient care.

This device is supplied as a kit package and is intended for facility use. It has received FDA 510(k) clearance with K number K072412 and is classified as a class II medical device under product code CBK. The device is regulated under number 868.5895 and is manufactured by Drager Medical AG & Co. Kgaa.

Other devices from Drager Medical AG & Co. Kgaa

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Option SmartCare for EvitaXL used for?

    The Option SmartCare for EvitaXL is a CO2 sensor CapnoSmart device designed to monitor carbon dioxide levels during patient care when used with EvitaXL ventilators. It is part of a SmartCare Kit Capno Package intended for facility use.

  • What models are available for the SmartCare CapnoSmart CO2 sensor?

    The SmartCare CapnoSmart CO2 sensor is available in models 8415941, 8415942, and 6871500. These models are specifically designed for use with the EvitaXL ventilator system.

  • What is the regulatory status of this device?

    The Option SmartCare for EvitaXL has received FDA 510(k) clearance with K number K072412. It is classified as a class II medical device under product code CBK and is regulated under number 868.5895.

  • How is the SmartCare Kit Capno Package supplied?

    The device is supplied as a kit package specifically designed for facility use. The kit includes the CO2 sensor CapnoSmart device and all necessary components for monitoring carbon dioxide levels during patient care with EvitaXL ventilators.