Ohmeda Oxygen Blender

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

510(k) Number

K853905 ↗

FDA Product Code

BZR

Device Class

Class II

Regulation

21 CFR Part 868.5330

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K072157 Active Cleared 27 Aug 2007

• Ohmeda Medical Omnibed

  Class II

  FDA 510(k) K993407 Active Cleared 5 Jan 2000

• Ohmeda 7900 Anesthesia Ventilator

  Class II

  FDA 510(k) K960964 Active Cleared 27 Sep 1996

• Biliblanket Plus High Output Phototherapy System

  Class II

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• Cpu-1 Intensive Care Ventilator

  Class II

  FDA 510(k) K871398 Active Cleared 7 May 1987

• Ohmeda 9000 Syringe Pump

  Class II

  FDA 510(k) K896023 Active Cleared 4 Jan 1990

See all devices from Ohmeda Medical →

• What is the Ohmeda Oxygen Blender used for?

  The Ohmeda Oxygen Blender is used to mix and deliver controlled concentrations of oxygen and other gases for respiratory support, specifically as a Mixer, Breathing Gases, Anesthesia Inhalation device in clinical settings.

• Is the Ohmeda Oxygen Blender reusable or single-use?

  The Ohmeda Oxygen Blender is supplied as a reusable unit, meaning it is designed for multiple uses after proper cleaning, calibration, and maintenance between patients.

• What regulatory pathway was used for the Ohmeda Oxygen Blender?

  The Ohmeda Oxygen Blender received traditional 510(k) clearance (K853905) based on substantial equivalence to a legally marketed predicate device, as indicated in its authorization data.

• What class is the Ohmeda Oxygen Blender under FDA regulations?

  The Ohmeda Oxygen Blender is classified as a Class II medical device under FDA regulation number 868.5330, which governs Mixer, Breathing Gases, Anesthesia Inhalation devices.

• What maintenance does the Ohmeda Oxygen Blender require?

  As a reusable unit, the Ohmeda Oxygen Blender requires regular calibration and maintenance to ensure accurate gas mixing and delivery, consistent with its classification and intended use in anesthesia and respiratory care.