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SK MED M201 MIXER

by Sk Med

510(k) K022864

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 · Abbreviated NumberK022864 Date11 Apr 2003ClearedStatusActive

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  • Withdrawn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, 25 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 SK MED M201 MIXER is a breathing gas mixer used in clinical settings to blend air and oxygen. It is classified as a Mixer, Breathing Gases, Anesthesia Inhalation under FDA regulation 868.5330 and is intended for use in anesthesiology applications.

The device accepts air and oxygen supply inputs and allows manual adjustment of oxygen concentration from 21% to 100% and flow rate from 0 to 30 L/min. It was cleared via the FDA 510(k) process under K022864 with a substantially equivalent decision on April 11, 2003, and is classified as a Class II medical device.

Other devices from Sk Med

Questions

AI-generated answers, 25 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 SK MED M201 MIXER used for?

    The SK MED M201 MIXER is a breathing gas mixer used in clinical settings to blend air and oxygen for anesthesiology applications, allowing precise control of oxygen concentration and flow during anesthesia delivery.

  • How is the oxygen concentration and flow rate adjusted on the SK MED M201 MIXER?

    The device allows manual adjustment of oxygen concentration from 21% to 100% and flow rate from 0 to 30 L/min via its control mechanisms, enabling clinicians to tailor the gas mixture to patient needs during anesthesia.

  • What regulatory pathway was used for the SK MED M201 MIXER and when was it cleared?

    The SK MED M201 MIXER was cleared via the FDA 510(k) process under submission K022864, receiving a substantially equivalent decision on April 11, 2003, based on its similarity to a legally marketed predicate device.