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Porous Media DBF23 Disposable Respiratory Filter

by Porous Media Corp. 2 variants

510(k) K964979

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 NumberK964979 Date11 Mar 1997ClearedStatusActive

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  • Withdrawn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, 24 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 Porous Media DBF23 Disposable Respiratory Filter is a bacterial breathing-circuit filter. It is designed to be used within a breathing circuit to filter gases.

This device is supplied as a single-use, disposable component. It has received FDA 510(k) clearance under the regulation number 868.5260.

Other devices from Porous Media Corp.

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Questions

AI-generated answers, 24 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 Porous Media DBF23?

    This device is a bacterial breathing-circuit filter designed to be integrated into a breathing circuit to filter gases during use.

  • Is this filter intended for multiple uses?

    No, the Porous Media DBF23 is supplied as a single-use, disposable component and should not be reused.

  • What is the regulatory status of this device?

    The Porous Media DBF23 has received FDA 510(k) clearance under regulation number 868.5260, which classifies it as a bacterial filter for breathing circuits.