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Respir Gard-II Oxygard Hydrogard-Spiro

by Marquest Medical Products, Inc.

510(k) K833267

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 NumberK833267 Date28 Oct 1983ClearedStatusActive

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  • Withdrawn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
CAH
Device Class
Class II
Regulation
21 CFR Part 868.5260
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.

This device is a bacterial filter for breathing circuits, as defined by its device type and classification under regulation number 868.5260. It is intended for use in anesthesiology applications to filter bacteria from breathing gas pathways.

The device was cleared via the FDA 510(k) process under K833267, with a traditional clearance decision dated October 28, 1983. It is manufactured by Marquest Medical Products, Inc. and classified as a Class II medical device under the product code CAH.

Other devices from Marquest Medical Products, Inc.

See all devices from Marquest Medical Products, Inc. →

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 RESPIR GARD-II OXYGARD HYDROGARD-SPIRO used for?

    This device is a bacterial filter for breathing circuits, intended for use in anesthesiology applications to filter bacteria from breathing gas pathways, as defined by its classification under regulation number 868.5260.

  • How was the RESPIR GARD-II OXYGARD HYDROGARD-SPIRO cleared for market?

    The device was cleared via the FDA 510(k) process under submission K833267, with a traditional clearance decision issued on October 28, 1983, based on a determination of substantial equivalence.

  • Is the RESPIR GARD-II OXYGARD HYDROGARD-SPIRO a single-use or reusable device?

    The device data does not specify whether the RESPIR GARD-II OXYGARD HYDROGARD-SPIRO is single-use or reusable; therefore, no conclusion can be drawn about its reusability from the provided information.

  • What regulatory classification does the RESPIR GARD-II OXYGARD HYDROGARD-SPIRO hold?

    The device is classified as a Class II medical device under the FDA product code CAH, as indicated in the authorization and device classification data.

  • Who manufactures the RESPIR GARD-II OXYGARD HYDROGARD-SPIRO and where are they located?

    The device is manufactured by Marquest Medical Products, Inc., located at 112 Inverness Cir., Suite A, Englewood, CO 80112, United States.