Skip to content

Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)

by Draeger Medical B.V. 510(k)

Active United States

510(k) K082600

Overview

The Oxylog 2000 Plus System and Basic Device are time-cycled, volume-controlled ventilators designed for emergency and transport use. They provide mandatory or assisted ventilation with pressure support, delivering tidal volumes from 100 ml upward. These devices are classified as continuous-use ventilators for facility deployment, supporting both invasive and non-invasive ventilation modes.

Intended for trained healthcare professionals, these devices are supplied as reusable medical equipment and are regulated under FDA 510(k) clearance (K082600). The systems are intended for facility-based use, adhering to regulatory standards for Class II devices (21 CFR 868.5895). No additional sterility or single-use specifications are indicated in the regulatory data.

AI-generated from registry data, 19 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 NumberK082600 Date26 Nov 2008ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0691-2016 FDA Class I initiated 22 Dec 2015
    • Terminated Z-0692-2016 FDA Class I initiated 22 Dec 2015

    Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.

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 Draeger Medical B.V.

  • Oxylog 3000

    Class II

  • Carina Home

    Class II

Questions

  • What is the Oxylog 2000 Plus System designed for?

    The Oxylog 2000 Plus System is designed for emergency and transport use as a time-cycled, volume-controlled ventilator that provides mandatory or assisted ventilation with pressure support, delivering tidal volumes from 100 ml upward for both invasive and non-invasive ventilation modes.

  • How is the Oxylog 2000 Plus System supplied?

    The Oxylog 2000 Plus System is supplied as reusable medical equipment intended for facility-based use by trained healthcare professionals, with no single-use or sterility specifications indicated in the regulatory data.

  • What is the regulatory status of the Oxylog 2000 Plus System?

    The Oxylog 2000 Plus System is regulated under FDA 510(k) clearance with K number K082600, classified as a Class II device under 21 CFR 868.5895 for continuous-use ventilators in facility settings.

  • What are the available models of the Oxylog 2000 Plus System?

    The Oxylog 2000 Plus System is available in two models: the OXYLOG 2000 PLUS SYSTEM (Model 5705080) and the OXYLOG 2000 PLUS BASIC DEVICE (Model 5705082), both designed for similar ventilation applications.