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Bacterial and Viral Filter

by F.L.W. Plastics, Inc. 510(k)

Active United States

510(k) K895233

Overview

A bacterial and viral filter is a device used in breathing circuits to prevent pathogen transmission by capturing airborne bacteria and viruses with high efficiency. It is designed for use in respiratory and anesthesia applications, including ventilators, anesthesia machines, scavenging circuits, mechanical ventilation, and manual ventilation such as bag valve mask (BVM).

The filter is supplied as a single-patient, single-session use device, typically packaged in cases of 50 units. It features standard ISO 5356-1 connectors for compatibility with breathing and scavenging circuits. The device received FDA 510(k) clearance (K895233) on November 15, 1989, and is classified as a Class II medical device under regulation number 868.5260.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895233 Date15 Nov 1989ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from F.L.W. Plastics, Inc.

Questions

  • What is the bacterial and viral filter used for?

    The bacterial and viral filter is used in breathing circuits to prevent pathogen transmission by capturing airborne bacteria and viruses with high efficiency. It is designed for use in respiratory and anesthesia applications, including ventilators, anesthesia machines, scavenging circuits, mechanical ventilation, and manual ventilation such as bag valve mask (BVM).

  • How is the bacterial and viral filter supplied and packaged?

    The filter is supplied as a single-patient, single-session use device, typically packaged in cases of 50 units. This ensures each filter is used for one patient during one session before disposal to maintain infection control.

  • What type of connectors does the bacterial and viral filter have for compatibility?

    The device features standard ISO 5356-1 connectors, which ensure compatibility with a wide range of breathing and scavenging circuits used in ventilators, anesthesia machines, and other respiratory equipment.

  • Is the bacterial and viral filter reusable or single-use?

    The filter is designed for single-patient, single-session use only, meaning it is intended to be used on one patient during one procedure or session and then discarded. It is not intended for reuse, reprocessing, or multiple patient use to prevent cross-contamination.