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LNI MGV Medical Gas Mixer

by P.A. Mccauley, Inc.

510(k) K854769

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 NumberK854769 Date5 Jun 1986ClearedStatusActive

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  • Withdrawn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, 19 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 LNI MGV Medical Gas Mixer is a Mixer, Breathing Gases, Anesthesia Inhalation (per FDA nomenclature), designed to blend and regulate medical gases for anesthesia delivery. It ensures precise gas mixture ratios to support controlled ventilation and patient safety during surgical procedures.

This device is intended for use in operating rooms and anesthesia care settings, supplied as a reusable medical instrument. It adheres to FDA 510(k) clearance (K854769) under regulation number 868.5330 and is classified as a Class II device. No specific sterility or MRI safety information is provided in the regulatory data.

Questions

AI-generated answers, 19 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 primary purpose of the LNI MGV Medical Gas Mixer in an operating room setting?

    The LNI MGV Medical Gas Mixer is designed to blend and regulate medical gases specifically for anesthesia inhalation during surgical procedures. It ensures precise control of gas mixture ratios to support safe and controlled ventilation for patients, which is critical in anesthesia care settings.

  • Is the LNI MGV Medical Gas Mixer intended for single-use or reusable applications?

    The LNI MGV Medical Gas Mixer is supplied as a reusable medical instrument, meaning it is designed for repeated use after proper cleaning, maintenance, and sterilization procedures. This aligns with its classification as a reusable device in anesthesia care environments.

  • What regulatory pathway was followed for the FDA clearance of this device?

    The LNI MGV Medical Gas Mixer received FDA clearance through a Traditional 510(k) pathway, specifically under regulation number 868.5330. It was determined to be substantially equivalent to a predicate device and was reviewed by the Anesthesiology (AN) Advisory Committee. The clearance number assigned is K854769.

  • Are there any specific storage requirements mentioned for the LNI MGV Medical Gas Mixer?

    The provided regulatory data does not include explicit storage instructions for the LNI MGV Medical Gas Mixer. However, as a reusable medical device, it should be stored in a clean, dry environment following manufacturer guidelines to ensure proper maintenance and longevity.