Skip to content

Bmd Air/Oxygen Blender

by Biomedical Devices, Inc.

510(k) K925982

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 NumberK925982 Date7 Oct 1993ClearedStatusActive

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  • Withdrawn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
BZR
Device Class
Class II
Regulation
21 CFR Part 868.5330
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The Bmd Air/Oxygen Blender is a mixer for breathing gases, used in anesthesia inhalation. It is designed to mix medical grade air and oxygen to any concentration from 21% to 100% oxygen. The device is used in the field of anesthesiology.

The Bmd Air/Oxygen Blender is supplied with a product code of BZR and is regulated under the number 868.5330. It has been cleared by the FDA under the traditional clearance type with the k number K925982. The device is intended for use in medical settings, with specific details on its use and operation not provided in the available data.

Other devices from Bio-Medical Devices, Inc.

See all devices from Bio-Medical Devices, Inc. →

Questions

AI-generated answers, 22 Sep 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 BMD Air/Oxygen Blender used for?

    The BMD Air/Oxygen Blender is used in the field of anesthesiology to mix medical grade air and oxygen for anesthesia inhalation.

  • What are the oxygen concentration ranges of the BMD Air/Oxygen Blender?

    The device can mix oxygen concentrations from 21% to 100%.

  • Is the BMD Air/Oxygen Blender cleared by the FDA?

    Yes, the BMD Air/Oxygen Blender has been cleared by the FDA under the traditional clearance type with the k number K925982.

  • What is the product code of the BMD Air/Oxygen Blender?

    The product code of the BMD Air/Oxygen Blender is BZR.