Skip to content

Gasline Filter, #EC-GLF Series

by Gish Biomedical, Inc.

510(k) K832935

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 NumberK832935 Date22 Nov 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  • Withdrawn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, 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 Gasline Filter, #EC-GLF Series is a bacterial filter designed for breathing circuits. It is intended to filter out bacteria from the gas lines in medical breathing systems.

This device is supplied as a single-use product and is not MRI compatible. It is regulated under FDA 510(k) clearance with product code CAH and regulation number 868.5260, classified as a Class II device for bacterial filtration in breathing circuits within the anesthesiology specialty.

Other devices from Gish Biomedical, Inc.

See all devices from Gish Biomedical, Inc. →

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 Gasline Filter EC-GLF Series used for?

    The Gasline Filter EC-GLF Series is a bacterial filter designed specifically for breathing circuits in medical systems. It filters out bacteria from gas lines in anesthesiology breathing systems to help maintain sterile conditions during procedures.

  • Is the Gasline Filter EC-GLF Series reusable or single-use?

    The Gasline Filter EC-GLF Series is supplied as a single-use product only. It should not be reused or resterilized for patient safety and to maintain its filtration effectiveness.

  • What are the regulatory classifications for the Gasline Filter EC-GLF Series?

    This device is regulated under FDA 510(k) clearance with product code CAH and regulation number 868.5260. It is classified as a Class II device for bacterial filtration in breathing circuits within the anesthesiology specialty.

  • Is the Gasline Filter EC-GLF Series compatible with MRI procedures?

    No, the Gasline Filter EC-GLF Series is not MRI compatible. It should not be used in MRI environments as it may not function properly or could pose safety risks in such conditions.