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Non-Invasive Ventilation NIV Option, Model 84 14 474

by Drager Medizintechnik GmbH 510(k)

Active United States

510(k) K010093

Overview

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. This device is classified as a continuous ventilator under regulation number 868.5895 and is substantially equivalent to a legally marketed predicate device.

It is supplied as a facility-use device, cleared via the FDA 510(k) pathway under K010093, and is intended for use in clinical settings such as ICUs. The device is manufactured by Drager Medizintechnik GmbH and falls under product code CBK with device class II.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK010093 Date14 Jun 2001ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2325-2008 FDA Unclassified (pre-2012) initiated 2 Jul 2008
    • Terminated Z-2326-2008 FDA Unclassified (pre-2012) initiated 2 Jul 2008

    Audible power failure alarm was not enunciated at the required volume

    • Terminated Z-0954-03 FDA Unclassified (pre-2012) initiated 7 May 2003

    software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.

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

Other devices from Drager Medizintechnik GmbH

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Questions

  • What is the NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 used for?

    This device is a continuous ventilator (respirator) intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas, making it suitable for supporting respiration in clinical environments where ventilatory support is required.

  • How is the NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 supplied and where is it intended for use?

    The device is supplied as a facility-use device and is intended for use in clinical settings such as intensive care units (ICUs), indicating it is designed for stationary use within healthcare facilities rather than for individual patient transport or home use.

  • What regulatory pathway was used to clear the NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474?

    The device was cleared via the FDA 510(k) pathway under submission number K010093, demonstrating substantial equivalence to a legally marketed predicate device, which is the standard regulatory route for moderate-risk medical devices in the United States.