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Sedara Gas Mixer, Sedara Scavenger Model: 03, 04

by Linde Healthcare AB

510(k) K101286

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 NumberK101286 Date20 Oct 2011ClearedStatusActive

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  • Withdrawn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, 21 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 Sedara Gas Mixer is a device that blends USP N2O and O2 to a fixed 50%/50% (V/V) concentration and delivers gas on-demand to spontaneously breathing patients via an internal demand valve and breathing circuit with a hand-held face mask. It includes a Sedara Scavenger to remove exhaled gases via hospital waste disposal. This device is classified as a Mixer, Breathing Gases, Anesthesia Inhalation and is intended for use by healthcare professionals in clinical settings.

The Sedara Gas Mixer, Sedara Scavenger Model: 03, 04 is manufactured by Linde Healthcare AB and was cleared by the FDA on October 20, 2011, with a 510(k) number K101286. It is a Class II medical device with product code BZR and regulation number 868.5330. The device is designed for use in anesthesiology and requires operation by healthcare professionals in clinical settings.

Questions

AI-generated answers, 21 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 Sedara Gas Mixer used for?

    The Sedara Gas Mixer is designed to blend USP N2O and O2 to a fixed 50%/50% (V/V) concentration and delivers gas on-demand to spontaneously breathing patients via an internal demand valve and breathing circuit with a hand-held face mask. It includes a Sedara Scavenger to remove exhaled gases.

  • Is the Sedara Gas Mixer a single-use or reusable device?

    The device is designed for multiple uses in clinical settings. It is a Class II medical device intended for operation by healthcare professionals in anesthesiology departments and other clinical environments where gas mixing and scavenging are required.

  • What are the regulatory approvals for the Sedara Gas Mixer?

    The Sedara Gas Mixer, Sedara Scavenger Model: 03, 04 was cleared by the FDA on October 20, 2011, with a 510(k) number K101286. It is classified as a Class II medical device with product code BZR and regulation number 868.5330.

  • How is the Sedara Gas Mixer supplied and stored?

    The device is supplied as a complete system including the gas mixer, scavenger, breathing circuit, and hand-held face mask. It should be stored in a clean, dry environment away from extreme temperatures and direct sunlight to maintain proper functionality.