Mesa II Oxygen Concentrator Model: T2000 Series

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K100920 ↗

FDA Product Code

CAW

Device Class

Class II

Regulation

21 CFR Part 868.5440

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Integra Oxygen Concentrators Model 6400-Om

  Class II

  FDA 510(k) K003472 Active Cleared 4 Jun 2001

• Integra Oxygen Concentrator, Model 6323A-Om-10

  Class II

  FDA 510(k) K042262 Active Cleared 10 Sep 2004

• Omni 2 Oxygen System

  Class II

  FDA 510(k) K083163 Active Cleared 20 Oct 2009

• Omni Oxygen System, Model 1000

  Class II

  FDA 510(k) K013931 Active Cleared 27 Mar 2002

• Mesa Oxygen Concentrator, Model 2-6000 Series

  Class II

  FDA 510(k) K091541 Active Cleared 31 Dec 2009